The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors.

Background Histotripsy is a nonthermal, nonionizing, noninvasive, focused US technique that relies on cavitation for mechanical tissue breakdown at the focal point. Preclinical data have shown its safety and technical success in the ablation of liver tumors. Purpose To evaluate the safety and technical success of histotripsy in destroying primary or metastatic liver tumors. Materials and Methods The parallel United States and European Union and England #HOPE4LIVER trials were prospective, multicenter, single-arm studies. Eligible patients were recruited at 14 sites in Europe and the United States from January 2021 to July 2022. Up to three tumors smaller than 3 cm in size could be treated. CT or MRI and clinic visits were performed at 1 week or less preprocedure, at index-procedure, 36 hours or less postprocedure, and 30 days postprocedure. There were co-primary end points of technical success of tumor treatment and absence of procedure-related major complications within 30 days, with performance goals of greater than 70% and less than 25%, respectively. A two-sided 95% Wilson score CI was derived for each end point. Results Forty-four participants (21 from the United States, 23 from the European Union or England; 22 female participants, 22 male participants; mean age, 64 years ± 12 [SD]) with 49 tumors were enrolled and treated. Eighteen participants (41%) had hepatocellular carcinoma and 26 (59%) had non-hepatocellular carcinoma liver metastases. The maximum pretreatment tumor diameter was 1.5 cm ± 0.6 and the maximum post-histotripsy treatment zone diameter was 3.6 cm ± 1.4. Technical success was observed in 42 of 44 treated tumors (95%; 95% CI: 84, 100) and procedure-related major complications were reported in three of 44 participants (7%; 95% CI: 2, 18), both meeting the performance goal. Conclusion The #HOPE4LIVER trials met the co-primary end-point performance goals for technical success and the absence of procedure-related major complications, supporting early clinical adoption. Clinical trial registration nos. NCT04572633, NCT04573881 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Nezami and Georgiades in this issue.

Safety and efficacy of histotripsy delivery through overlying gas-filled small bowel in an ex vivo swine model.

PURPOSE: To evaluate the safety and efficacy of performing histotripsy through overlying gas-filled bowel in an ex vivo swine model. METHODS: An ex vivo model was created to simulate histotripsy treatment of solid organs through gas-filled bowel. Spherical 2.5 cm histotripsy treatments were performed in agar phantoms for each of five treatment groups: 1) control with no overlying bowel (n = 6), 2) bowel 0 cm above phantom (n = 6), 3) bowel 1 cm above phantom (n = 6), 4) bowel 2 cm above phantom (n = 6), and 5) bowel 0 cm above the phantom with increased treatment amplitude (n = 6). Bowel was inspected for gross and microscopic damage, and treatment zones were measured. A ray-tracing simulation estimated the percentage of therapeutic beam path blockage by bowel in each scenario. RESULTS: All histotripsy treatments through partial blockage were successful (24/24). No visible or microscopic damage was observed to intervening bowel. Partial blockage resulted in a small increase in treatment volume compared to controls (p = 0.002 and p = 0.036 for groups with bowel 0 cm above the phantom, p > 0.3 for bowel 1 cm and 2 cm above the phantom). Gas-filled bowel was estimated to have blocked 49.6%, 35.0%, and 27.3% of the therapeutic beam at 0, 1, and 2 cm, respectively. CONCLUSION: Histotripsy has the potential to be applied through partial gas blockage of the therapeutic beam path, as shown by this ex vivo small bowel model. Further work in an in vivo survival model appears indicated.

A comparison study of microwave ablation vs. histotripsy for focal liver treatments in a swine model.

OBJECTIVE: To compare the acute and chronic safety and treatment effects of non-invasive hepatic histotripsy vs. percutaneous microwave (MW) ablation in a healthy porcine model. METHODS: This was a dual-arm study in which each animal (n = 14) received either a single hepatic microwave (n = 6) or histotripsy (n = 6 single treatment; n = 2 double treatment) under ultrasound guidance. The goal was to create 2.5-3.0 cm short-axis treatments in similar locations across modalities. Animals were survived for 1 month with contrast-enhanced CT imaging on days 0, 2, 7, 14, and 28. On day 28, necropsy and histopathology were performed. RESULTS: All procedures were well-tolerated. MW ablation zones were longer and more oblong, but equivalent in the short axes to histotripsy zones on immediate post-procedure CT (p < 0.001 and p = 0.45, respectively). Overall, MW volumes were larger (21.4 cm3 vs. 13.4 cm3; p = 0.001) and histotripsy treatment zones were more spherical (p = 0.007). Histotripsy zones were close to the prescribed size (p < 0.001). Over the study period, histotripsy treatment zones decreased in volume while microwave ablation zones slightly increased (-83% vs. +17%, p = 0.001). There were several imaging-only findings: Branch portal vein thrombus with both histotripsy (7/8) and MW (6/6), hematoma in 2/6 MW only, and a gallbladder injury in 1/6 MW animals. The ablation zones demonstrated complete cellular destruction for both modalities. CONCLUSION: Histotripsy was associated with more spherical treatments, fewer biliary complications, and greater treatment zone involution. Hepatic MW and histotripsy treatment in a normal porcine model appear at least equally effective for creating treatment zones with a similar safety profile. KEY POINTS: • Microwave ablation and histotripsy for liver treatment in a healthy porcine model yield equivalent procedural tolerance and cellular destruction. • Histotripsy was associated with more spherical treatments, fewer biliary complications, and greater treatment zone involution over the 28-day follow-up period. • These findings confirm the safety and efficacy of hepatic histotripsy and support the pursuit of clinical trials to further evaluate the translatability of these results.

Artificial Intelligence-Aided Selection of Needle Pathways: Proof-of-Concept in Percutaneous Lung Biopsies.

PURPOSE: To evaluate the concordance between lung biopsy puncture pathways determined by artificial intelligence (AI) and those determined by expert physicians. MATERIALS AND METHODS: An AI algorithm was created to choose optimal lung biopsy pathways based on segmented thoracic anatomy and emphysema in volumetric lung computed tomography (CT) scans combined with rules derived from the medical literature. The algorithm was validated using pathways generated from CT scans of randomly selected patients (n = 48) who had received percutaneous lung biopsies and had noncontrast CT scans of 1.25-mm thickness available in picture archiving and communication system (PACS) (n = 28, mean age, 68.4 years ± 9.2; 12 women, 16 men). The algorithm generated 5 potential pathways per scan, including the computer-selected best pathway and 4 random pathways (n = 140). Four experienced physicians rated each pathway on a 1-5 scale, where scores of 1-3 were considered safe and 4-5 were considered unsafe. Concordance between computer and physician ratings was assessed using Cohen's κ. RESULTS: The algorithm ratings were statistically equivalent to the physician ratings (safe vs unsafe: κ¯=0.73; ordinal scale: κ¯=0.62). The computer and physician ratings were identical in 57.9% (81/140) of cases and differed by a median of 0 points. All least-cost "best" pathways generated by the algorithm were considered safe by both computer and physicians (28/28) and were judged by physicians to be ideal or near ideal. CONCLUSIONS: AI-generated lung biopsy puncture paths were concordant with expert physician reviewers and considered safe. A prospective comparison between computer- and physician-selected puncture paths appears indicated in addition to expansion to other anatomic locations and procedures.

Percutaneous CT-Guided Abdominal and Pelvic Biopsies: Comparison of an Electromagnetic Navigation System and CT Fluoroscopy.

PURPOSE: To compare electromagnetic navigation (EMN) with computed tomography (CT) fluoroscopy for guiding percutaneous biopsies in the abdomen and pelvis. MATERIALS AND METHODS: A retrospective matched-cohort design was used to compare biopsies in the abdomen and pelvis performed with EMN (consecutive cases, n = 50; CT-Navigation; Imactis, Saint-Martin-d'Hères, France) with those performed with CT fluoroscopy (n = 100). Cases were matched 1:2 (EMN:CT fluoroscopy) for target organ and lesion size (±10 mm). RESULTS: The population was well-matched (age, 65 vs 65 years; target size, 2.0 vs 2.1 cm; skin-to-target distance, 11.4 vs 10.7 cm; P > .05, EMN vs CT fluoroscopy, respectively). Technical success (98% vs 100%), diagnostic yield (98% vs 95%), adverse events (2% vs 5%), and procedure time (33 minutes vs 31 minutes) were not statistically different (P > .05). Operator radiation dose was less with EMN than with CT fluoroscopy (0.04 vs 1.2 µGy; P < .001), but patient dose was greater (30.1 vs 9.6 mSv; P < .001) owing to more helical scans during EMN guidance (3.9 vs 2.1; P < .001). CT fluoroscopy was performed with a mean of 29.7 tap scans per case. In 3 (3%) cases, CT fluoroscopy was performed with gantry tilt, and the mean angle out of plane for EMN cases was 13.4°. CONCLUSIONS: Percutaneous biopsies guided by EMN and CT fluoroscopy were closely matched for technical success, diagnostic yield, procedure time, and adverse events in a matched cohort of patients. EMN cases were more likely to be performed outside of the gantry plane. Radiation dose to the operator was higher with CT fluoroscopy, and patient radiation dose was higher with EMN. Further study with a wider array of procedures and anatomic locations is warranted.

Hepatic and Renal Histotripsy in an Anticoagulated Porcine Model.

PURPOSE: To determine the risk of mechanical vessel wall damage resulting in hemorrhage during and after hepatic and renal histotripsy in an anticoagulated in vivo porcine model. MATERIALS AND METHODS: Non-tumor-bearing pigs (n = 8; mean weight, 52.5 kg) were anticoagulated with warfarin (initial dose, 0.08 mg/kg) to a target prothrombin time (PT) of 30%-50% above baseline. A total of 15 histotripsy procedures were performed (kidney: n = 8, 2.0-cm sphere; liver: n = 7, 2.5-cm sphere). Treatments were immediately followed by computed tomography (CT) imaging. Animals were observed for 7 days while continuing anticoagulation, followed by repeat CT and necropsy. RESULTS: All animals survived to complete the entire protocol with no signs of disability or distress. Three animals had hematuria (pink urine without clots). Baseline PT values (mean, 16.0 seconds) were elevated to 22.0 seconds (37.5% above baseline, P = .003) on the day of treatment and to 28.8 seconds (77.8% above baseline, P < .001) on the day of necropsy. At the time of treatment, 5 of 8 (63%) animals were at a therapeutic anticoagulation level, and all 8 animals (100%) reached therapeutic levels by the time of necropsy. There were no cases of intraparenchymal, peritoneal, or retroperitoneal hemorrhage associated with any treatments despite 5 of 7 (71%) liver and all 8 (100%) kidney treatments extending to the organ surface. CONCLUSIONS: Liver and kidney histotripsy seems safe with no elevated bleeding risk in this anticoagulated animal model, supporting the possibility of histotripsy treatments in patients on anticoagulation.

A Comparison of Histotripsy and Percutaneous Cryoablation in a Chronic Healthy Swine Kidney Model.

PURPOSE: To compare the safety and efficacy of histotripsy with cryoablation in a chronic human-scale normal porcine kidney model. MATERIALS AND METHODS: Eighteen female domestic swine were divided evenly into histotripsy and cryoablation treatment arms. A planned 2-3 cm diameter treatment was performed under ultrasound (histotripsy) or ultrasound and computed tomography (CT) guidance (cryoablation). Contrast-enhanced CT and serum blood analysis were performed immediately postprocedure and on day 7, with either immediate killing (n = 3) or continued survival to day 30 (n = 6), at which time contrast-enhanced CT, serum blood analysis, and necropsy were performed. Animal welfare, treatment zone appearance, procedure-related adverse events, and histopathology of the treatment zones and surrounding tissues were assessed. RESULTS: Histotripsy treatment zones (mean ±standard deviation diameters, 2.7 ± 0.12 × 2.4 ± 0.19 × 2.4 ± 0.26 cm; volume, 8.3 ± 1.9 cm3) were larger than cryoablation zones (mean diameters, 2.2 ± 0.19 × 1.9 ± 0.13 × 1.7 ± 0.19 cm; volume, 3.9 ± 0.8 cm3; P < .001). At 30 days, histotripsy and cryoablation treatment zone volumes decreased by 96% and 83% on CT, respectively (P < .001). Perirenal hematomas were present after 8 of 9 (89%) cryoablation (mean volume, 22.2 cm3) and 1 of 9 (11%, P < .001) histotripsy (volume, 0.4 cm3) procedures, with active arterial extravasation in 4 of 9 (44%) cryoablation and no histotripsy animals (P = .206). All 9 histotripsy animals and 5 of 9 (56%) cryoablation animals had collecting system debris (P = .042). Changes in serum creatinine were similar between the groups (P = .321). CONCLUSIONS: Other than a higher rate of bleeding after cryoablation, the safety and early efficacy of histotripsy and cryoablation were comparable for creating treatment zones in a chronic normal porcine kidney model.

Clinical translation of abdominal histotripsy: a review of preclinical studies in large animal models.

Histotripsy is an emerging noninvasive, non-thermal, and non-ionizing focused ultrasound (US) therapy that can be used to destroy targeted tissue. Histotripsy has evolved from early laboratory prototypes to clinical systems which have been comprehensively evaluated in the preclinical environment to ensure safe translation to human use. This review summarizes the observations and results from preclinical histotripsy studies in the liver, kidney, and pancreas. Key findings from these studies include the ability to make a clinically relevant treatment zone in each organ with maintained collagenous architecture, potentially allowing treatments in areas not currently amenable to thermal ablation. Treatments across organ capsules have proven safe, including in anticoagulated models which may expand patients eligible for treatment or eliminate the risk associated with taking patients off anti-coagulation. Treatment zones are well-defined with imaging and rapidly resorb, which may allow improved evaluation of treatment zones for residual or recurrent tumor. Understanding the effects of histotripsy in animal models will help inform physicians adopting histotripsy for human clinical use.

Abdominal fellowship-trained versus generalist radiologist accuracy when interpreting MR and CT for the diagnosis of appendicitis.

OBJECTIVES: To compare the diagnostic accuracy of generalist radiologists working in a community setting against abdominal radiologists working in an academic setting for the interpretation of MR when diagnosing acute appendicitis among emergency department patients. METHODS: This observational study examined MR image interpretation (non-contrast MR with diffusion-weighted imaging and intravenous contrast-enhanced MR) from a prospectively enrolled cohort at an academic hospital over 18 months. Eligible patients had an abdominopelvic CT ordered to evaluate for appendicitis and were > 11 years old. The reference standard was a combination of surgery and pathology results, phone follow-up, and chart review. Six radiologists blinded to clinical information, three each from community and academic practices, independently interpreted MR and CT images in random order. We calculated test characteristics for both individual and group (consensus) diagnostic accuracy then performed Chi-square tests to identify any differences between the subgroups. RESULTS: Analysis included 198 patients (114 women) with a mean age of 31.6 years and an appendicitis prevalence of 32.3%. For generalist radiologists, the sensitivity and specificity (95% confidence interval) were 93.8% (84.6-98.0%) and 88.8% (82.2-93.2%) for MR and 96.9% (88.7-99.8%) and 91.8% (85.8-95.5%) for CT. For fellowship-trained radiologists, the sensitivity and specificity were 96.9% (88.2-99.5%) and 89.6% (82.8-94%) for MR and 98.4% (90.5-99.9%) and 93.3% (87.3-96.7%) for CT. No statistically significant differences were detected between radiologist groups (p = 1.0, p = 0.53, respectively) or when comparing MR to CT (p = 0.21, p = 0.17, respectively). CONCLUSIONS: MR is a reliable, radiation-free imaging alternative to CT for the evaluation of appendicitis in community-based generalist radiology practices. KEY POINTS: • There was no significant difference in MR image interpretation accuracy between generalist and abdominal fellowship-trained radiologists when evaluating sensitivity (p = 1.0) and specificity (p = 0.53). • There was no significant difference in accuracy comparing MR to CT imaging for diagnosing appendicitis for either sensitivity (p = 0.21) or specificity (p = 0.17). • With experience, generalist radiologists enhanced their MR interpretation accuracy as demonstrated by improved interpretation sensitivity (OR 2.89 CI 1.44-5.77, p = 0.003) and decreased mean interpretation time (5 to 3.89 min).

Microwave Ablation as Bridging to Liver Transplant for Patients with Hepatocellular Carcinoma: A Single-Center Retrospective Analysis.

PURPOSE: To evaluate the efficacy and safety of microwave (MW) ablation as first-line locoregional therapy (LRT) for bridging patients with hepatocellular carcinoma (HCC) to liver transplant. MATERIALS AND METHODS: This retrospective study evaluated 88 patients who received percutaneous MW ablation for 141 tumors as first-line LRT for HCC and who were listed for liver transplantation at a single medical center between 2011 and 2019. The overall survival (OS) rate statuses after liver transplant, waitlist retention, and disease progression were evaluated using the Kaplan-Meier techniques. RESULTS: Among the 88 patients (72 men and 16 women; mean age, 60 years; Model for End-Stage Liver Disease score, 11.2) who were listed for transplant, the median waitlist time was 9.4 months (interquartile range, 5.5-18.9). Seventy-one (80.7%) patients received transplant after a median waitlist time of 8.5 months. Seventeen (19.3%) patients were removed from the waitlist; of these, 4 (4.5%) were removed because of tumors outside of the Milan criteria (HCC-specific dropout). No difference in tumor size or alpha-fetoprotein was observed in the transplanted versus nontransplanted patients at the time of ablation (2.1 vs 2.1 cm and 34.4 vs 34.7 ng/mL for transplanted vs nontransplanted, respectively; P > .05). Five (5.1%) of the 88 patients experienced adverse events after ablation; however, they all recovered. There were no cases of tract seeding. The local tumor progression (LTP) rate was 7.2%. The OS status after liver transplant at 5 years was 76.7%, and the disease-specific survival after LTP was 89.6%, with a median follow-up of 61 months for all patients. CONCLUSIONS: MW ablation appears to be safe and effective for bridging patients with HCC to liver transplant without waitlist removal from seeding, adverse events, or LTP.

First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study.

Rationale Current hepatic locoregional therapies are limited in terms of effectiveness and toxicities. Given promising pre-clinical results, a first in-human trial was designed to assess the technical effectiveness and safety profile of histotripsy, a noninvasive, non-thermal, non-ionizing focused ultrasound therapy that creates precise, predictable tissue destruction, in patients with primary and secondary liver tumors.Methods A multicenter phase I trial (Theresa Study) was performed in a single country with 8 weeks of planned follow-up. Eight of fourteen recruited patients were deemed eligible and enrolled in the study. Hepatic histotripsy, was performed with a prototype system (HistoSonics, Inc., Ann Arbor, MI). Eleven tumors were targeted in the 8 patients who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 patients (7 tumors), breast cancer metastases in 1 (1 tumor), cholangiocarcinoma metastases in 1 (2 tumors), and hepatocellular carcinoma (HCC) in 1 (1 tumor). The primary endpoint was acute technical success, defined as creating a zone of tissue destruction per planned volume assessed by MRI 1-day post-procedure. Safety (device-related adverse events) through 2 months was a secondary endpoint.Results The 8 patients had a median age of 60.4 years with an average targeted tumor diameter of 1.4 cm. The primary endpoint was achieved in all procedures. The secondary safety profile endpoint identified no device-related adverse events. Two patients experienced a continuous decline in tumor markers during the eight weeks following the procedure.Conclusions This first-in-human trial demonstrates that hepatic histotripsy effectively destroys liver tissue in a predictable manner, correlating very well with the planned histotripsy volume, and has a high safety profile without any device-related adverse events. Based on these results, the need for more definitive clinical trials is warranted. Trial Registration: Study to Evaluate VORTX Rx (Theresa). NCT03741088. https://clinicaltrials.gov/ct2/show/NCT03741088 KEY POINTSHistotripsy, a new noninvasive, non-thermal, non-ionizing focused ultrasound therapy, safely created a zone of tissue destruction in the liver that correlated very well with the pre-defined planned tissue destruction volume.In this first human trial histotripsy was well tolerated with no histotripsy device-related adverse events and its primary endpoint of acute technical success was achieved in all 8 enrolled patients with primary or secondary liver tumors.This new locoregional therapy for patients with liver tumors is safe and effective, warranting further trials.

Percutaneous Lung Biopsy with Pleural and Parenchymal Blood Patching: Results and Complications from 1,112 Core Biopsies.

PURPOSE: To evaluate the outcomes of computed tomography (CT) fluoroscopy-guided core lung biopsies with emphasis on diagnostic yield, complications, and efficacy of parenchymal and pleural blood patching to avoid chest tube placement. METHODS: This is a single-center retrospective analysis of CT fluoroscopy-guided percutaneous core lung biopsies between 2006 and 2020. Parenchymal blood patching during introducer needle withdrawal was performed in 74% of cases as a preventive measure, and pleural blood patching was the primary salvage maneuver for symptomatic or growing pneumothorax in 60 of 83 (72.2%) applicable cases. RESULTS: A total of 1,029 patients underwent 1,112 biopsies (532 men; mean age, 66 years; 38.6%, history of emphysema; lesion size, 16.7 mm). The diagnostic yield was 93.6% (1,032/1,103). Fewer complications requiring intervention were observed in patients who underwent parenchymal blood patching (5.7% vs 14.2%, P < .001). Further intervention was required in 83 of 182 pneumothorax cases, which included the following: (a) pleural blood patch (5.4%, 60/1,112), (b) chest tube placement without a pleural blood patch attempt (1.5%, 17/1,112), and (c) simple aspiration (0.5%, 6/1,112). Pleural blood patch as monotherapy was successful in 83.3% (50/60) of cases without need for further intervention. The overall chest tube rate was 2.6% (29/1,112). Emphysema was the only significant risk factor for complications requiring intervention (P ≤ .001). CONCLUSIONS: Parenchymal blood patching during introducer needle withdrawal decreased complications requiring intervention. Salvage pleural blood patching reduced the frequency of chest tube placement for pneumothorax.

Noninvasive thyroid histotripsy treatment: proof of concept study in a porcine model.

INTRODUCTION: This study was performed to determine the feasibility and safety of creating superficial histotripsy treatment in a live porcine thyroid model. METHODS: The porcine thymus comparable in size, shape and location to the human thyroid was used for this study. This model has been used for thyroid surgery studies due to the diminutive size of the porcine thyroid. Four female swine underwent a total of eight histotripsy treatments performed with a prototype therapy system (HistoSonics, Inc., Ann Arbor, MI). Two treatments were performed in each animal: a spherical 1.0 × 1.0 × 1.0 cm and ovoid 1.0 × 1.0 × 2.0 cm treatment zones. MRI immediately post-procedure was evaluated for histotripsy treatment zone size and imaging appearance, followed immediately by sacrifice. Tissue was then reviewed for percent cellular destruction and precision. RESULTS: Treatment zones measured on post treatment MRI were similar to prescribed volumes (spherical = 0.60 (+/- 0.11) cm3, ovoid = 1.23 (+/- 0.40) cm3, p > 0.05 vs. prescribed). MRI demonstrated well demarcated treatment zones and imaging findings consistent with cellular destruction. Histology demonstrated sharp transitions to normal tissue (mean 0.33 (+/- 0.13) cm), and high degrees of cellular destruction (mean 76% (+/- 12.5), range of 50-100%) in the treated tissue. Edema within the overlying muscle was seen in 2/8 treatments. CONCLUSION: Histotripsy is capable of safely creating precise histotripsy treatments within the superficial neck of a porcine thyroid model without evidence of considerable complications.

Magnetic resonance imaging versus computed tomography and ultrasound for the diagnosis of female pelvic pathology.

OBJECTIVES: We sought to determine the diagnostic accuracy of magnetic resonance (MR) imaging compared with computed tomography (CT) and ultrasound (US) when evaluating for five common pelvic pathologies among women presenting to the emergency department (ED) with right lower quadrant abdominal pain. METHODS: This prospective, single-center study was conducted at an academic ED as a sub-analysis of a direct comparison of the diagnostic accuracy of CT and MR in the evaluation of appendicitis. Patients were eligible for participation in the parent study if they were at least 12 years old and had a CT performed for evaluation of possible appendicitis. In the current study, only female patients who also underwent pelvic US were included. Three radiologists independently interpreted each MR examination specifically for the presence of pelvic pathology, knowing that patients had initially undergone imaging evaluation for possible appendicitis. The determination of an independent expert panel of two radiologists and one emergency physician based on surgical pathology, comprehensive chart review, clinical information, and follow-up phone calls served as the reference standard. Test characteristics of MR, CT, and US were calculated based on this; the main outcome measure was the summary sensitivity and specificity of MR versus CT and US. RESULTS: Forty-one participants were included with a mean age of 27.6 ± 10.8 years. The MR consensus interpretation had an overall sensitivity and specificity of 57.1% (CI 38.8-75.5%) and 97.2% (CI 94.7-99.6%) respectively, for detecting any of the five pelvic pathologies. By comparison, CT exhibited sensitivity and specificity of 66.7% (CI 50.0-83.5%) and 98.3% (CI 96.4-100.0%) while it was 64.3% (CI 46.5-82.0%) and 97.7% (CI 95.6-99.9%) for US, respectively. No significant differences were identified when comparing these modalities. Overall, Fleiss' kappa interrater reliability value for MR interpretation was 0.75, corresponding to substantial agreement between the three readers. CONCLUSIONS: In women who might otherwise undergo multiple imaging tests to evaluate gastrointestinal versus pelvic pathologies, our data suggest that MR may be an acceptable first-line imaging test.

Radiofrequency and microwave ablation in a porcine liver model: non-contrast CT and ultrasound radiologic-pathologic correlation.

Purpose: The goal of this study was to compare intra-procedural radiofrequency (RF) and microwave ablation appearance on non-contrast CT (NCCT) and ultrasound to the zone of pathologic necrosis.Materials and methods: Twenty-one 5-min ablations were performed in vivo in swine liver with (1) microwave at 140 W, (2) microwave at 70 W, or (3) RF at 200 W (n = 7 each). CT and US images were obtained simultaneously at 1, 3, and 5 min during ablation and 2, 5, and 10 min post-ablation. Each ablation was sectioned in the plane of the ultrasound image and underwent vital staining to delineate cellular necrosis. CT was reformatted to the same plane as the ultrasound transducer and transverse diameters of gas and hypoechoic/hypoattenuating zones at each time point were measured. CT, ultrasound and gross pathologic diameter measurements were compared using Student's t-tests and linear regression.Results: Visible gas and the hypoechoic zone on US images were more predictive of the pathologic ablation zone than on NCCT images (p < 0.05). The zone of necrosis was larger than the zone of visible gas on US (mean 3.2 mm for microwave, 6.4 mm for RF) and NCCT (7.6 mm microwave, 13.9 mm RF) images (p < 0.05). The zone of visible gas and hypoechoic zone on US are more predictive of pathology with microwave ablations when compared with RF ablations (p < 0.05).Conclusion: When evaluating images during energy delivery, US is more accurate than CT and microwave- more predictable than RF-ablation based on correlation with in-plane pathology.

Opportunistic Osteoporosis Screening at Routine Abdominal and Thoracic CT: Normative L1 Trabecular Attenuation Values in More than 20 000 Adults.

Background Abdominal and thoracic CT provide a valuable opportunity for osteoporosis screening regardless of the clinical indication for imaging. Purpose To establish reference normative ranges for first lumbar vertebra (L1) trabecular attenuation values across all adult ages to measure bone mineral density (BMD) at routine CT. Materials and Methods Reference data were constructed from 20 374 abdominal and/or thoracic CT examinations performed at 120 kV. Data were derived from adults (mean age, 60 years ± 12 [standard deviation]; 56.1% [11 428 of 20 374] women). CT examinations were performed with (n = 4263) or without (n = 16 111) intravenous contrast agent administration for a variety of unrelated clinical indications between 2000 and 2018. L1 Hounsfield unit measurement was obtained either with a customized automated tool (n = 11 270) or manually by individual readers (n = 9104). The effects of patient age, sex, contrast agent, and manual region-of-interest versus fully automated L1 Hounsfield unit measurement were assessed using multivariable logistic regression analysis. Results Mean L1 attenuation decreased linearly with age at a rate of 2.5 HU per year, averaging 226 HU ± 44 for patients younger than 30 years and 89 HU ± 38 for patients 90 years or older. Women had a higher mean L1 attenuation compared with men (P < .008) until menopause, after which both groups had similar values. Administration of intravenous contrast agent resulted in negligible differences in mean L1 attenuation values except in patients younger than 40 years. The fully automated method resulted in measurements that were average 21 HU higher compared with manual measurement (P < .004); at intrapatient subanalysis, this difference was related to the level of transverse measurement used (midvertebra vs off-midline level). Conclusion Normative ranges of L1 vertebra trabecular attenuation were established across all adult ages, and these can serve as a quick reference at routine CT to identify adults with low bone mineral density who are at risk for osteoporosis. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Smith in this issue.

Risk Factors for Complications and Nondiagnostic Results following 1,155 Consecutive Percutaneous Core Renal Mass Biopsies.

PURPOSE: The purpose of this study was to evaluate patient, tumor and technical factors associated with procedural complications and nondiagnostic findings following percutaneous core renal mass biopsy. MATERIALS AND METHODS: We reviewed core renal mass biopsies from 2000 to 2017. Complications at 30 days or less were graded using the Clavien-Dindo system. Univariate and multivariable analyses were done to evaluate associations between clinical characteristics and the risk of complications or nondiagnostic findings. RESULTS: Of the 1,155 biopsies performed in a total of 965 patients procedural complications were identified in 24 patients (2.2%), including 5 (0.4%) with major complications (Clavien 3a or greater). No patients were identified with tumor seeding of the biopsy tract. Patient age, body mass index, gender, Charlson comorbidity index, smoking, mass diameter, nephrometry score, number of cores and prior biopsy were not associated with complication risk (p = 0.06 to 0.53). Complications were not increased for patients on aspirin or those with low platelets (25,000 to 160,000/µl blood) or a mildly elevated INR (international normalized ratio) (1.2 to 2.0, p = 0.16, 0.07 and 0.50, respectively). The complication risk was not increased during the initial 50 cases of a radiologist or when a trainee was present (p = 0.35 and 0.12, respectively). Nondiagnostic findings were present in 14.6% of biopsies. Independent predictors included cystic features, contrast enhancement, mass diameter and skin-to-mass distance (p <0.001, 0.002, 0.02 and 0.049, respectively). Radiologist experience was not associated with the nondiagnostic rate (p = 0.23). Prior nondiagnostic biopsy was not associated with an increased nondiagnostic rate on subsequent attempts (19.2% vs 14.2%, p = 0.23). CONCLUSIONS: Procedural complications following biopsy are rare even with low serum platelets, a mildly elevated INR or when the patient remains on aspirin. Cystic features, hypo-enhancement on imaging, a smaller mass diameter and a longer skin-to-tumor distance increase the risk of nondiagnostic findings.

Prospective evaluation of MRI compared with CT for the etiology of abdominal pain in emergency department patients with concern for appendicitis.

BACKGROUND: Computed tomography (CT) is commonly used in the Emergency Department (ED) to evaluate patients with abdominal pain, but exposes them to ionizing radiation, a possible carcinogen. MRI does not utilize ionizing radiation and may be an alternative. PURPOSE: To compare the sensitivity of MRI and CT for acute abdominopelvic ED diagnoses. STUDY TYPE: Prospective, observational cohort. POPULATION: ED patients ≥12 years old and undergoing CT for possible appendicitis. FIELD STRENGTH/SEQUENCE: 1.5 T MRI, including T1 -weighted, T2 -weighted, and diffusion-weighted imaging sequences. ASSESSMENT: Three radiologists independently interpreted each MRI and CT image set separately and blindly, using a standard case report form. Assessments included likelihood of appendicitis, presence of an alternative diagnosis, and likelihood that the alternative diagnosis was causing the patient's symptoms. An expert panel utilized chart review and follow-up phone interviews to determine all final diagnoses. Times to complete image acquisition and image interpretation were also calculated. STATISTICAL TESTS: Sensitivity was calculated for each radiologist and by consensus (≥2 radiologists in agreement) and are reported as point estimates with 95% confidence intervals. Two-sided hypothesis tests comparing the sensitivities of the three image types were conducted using Pearson's chi-squared test with the traditional significance level of P = 0.05. RESULTS: There were 15 different acute diagnoses identified on the CT/MR images of 113 patients. Using individual radiologist interpretations, the sensitivities of noncontrast-enhanced MRI (NCE-MR), contrast-enhanced MR (CE-MR), and CT for any acute diagnosis were 77.0% (72.6-81.4%), 84.2% (80.4-88.0%), and 88.7% (85.5-92.1%). Sensitivity of consensus reads was 82.0% (74.9-88.9%), 87.1% (81.0-93.2%), 92.2% (87.3-97.1%), respectively. There was no difference in sensitivities between CE-MR and CT by individual (P = 0.096) or consensus interpretations (P = 0.281), although NCE-MR was inferior to CT in both modes of analysis (P < 0.001, P = 0.031, respectively). DATA CONCLUSION: The sensitivity of CE-MR was similar to CT when diagnosing acute, nontraumatic abdominopelvic pathology in our cohort. LEVEL OF EVIDENCE: 2 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;50:1651-1658.

Tumor location does not impact oncologic outcomes for percutaneous microwave ablation of clinical T1a renal cell carcinoma.

OBJECTIVE: To evaluate the impact of anterior tumor location on oncologic efficacy, complication rates, and procedure duration for 151 consecutive biopsy-proven clinical T1a renal cell carcinoma (RCC) treated with percutaneous microwave (MW) ablation. METHODS: This single-center retrospective study was performed under a waiver of informed consent. One hundred forty-eight consecutive patients (103 M/45 F; median age 67 years, IQR 61-73) with 151 cT1a biopsy-proven RCC (median diameter 2.4 cm, IQR 1.9-3.0) were treated with percutaneous MW ablation between March 2011 and August 2017. Patient and procedural data collected included Charlson comorbidity index (CCI), RENAL nephrometry score (NS), use of hydrodisplacement, MW antennas/generator output/time, and procedure time (PT). Data were stratified by anterior, posterior, and midline tumor location and compared with the Kruskal-Wallis or chi-squared tests. The Kaplan-Meier method was used for survival analyses. RESULTS: Tumor size, NS, and use/volume of hydrodisplacement were similar for posterior and anterior tumors (p > 0.05). Patients with anterior tumors had a higher CCI (3 vs 4, p = 0.001). Median PT for posterior and anterior tumors was similar (100 vs 108 min, p = 0.26). Single session technical success and primary efficacy were achieved for all 151 tumors including 61 posterior and 67 anterior tumors. The 4 (3%) Clavien III-IV complications and 6 (4%) local recurrences were not associated with tumor location (p > 0.05). Three-year RFS, CSS, and OS were 95% (95% CI 0.87, 0.98), 100% (95% CI 1.0, 1.0), and 96% (95% CI 0.89, 0.98), respectively. CONCLUSIONS: The safety and efficacy of percutaneous microwave ablation for anterior and posterior RCC are similar. KEY POINTS: • The safety profile for percutaneous microwave ablation of anterior and posterior T1a renal cell carcinoma is equivalent. • Percutaneous microwave ablation of T1a renal cell carcinoma provides durable oncologic control regardless of tumor location. • Placement of additional microwave antennas and use of hydrodisplacement are associated with longer procedure times.

Percutaneous Microwave Tumor Ablation Is Safe in Patients with Cardiovascular Implantable Electronic Devices: A Single-Institutional Retrospective Review.

The risk of electromagnetic interference between microwave (MW) ablation and cardiac implantable electronic devices (CIEDs), ie, pacemakers and defibrillators, has not been fully evaluated. Fourteen MW ablations (kidney, n = 8; liver, n = 5; lung, n = 1) were performed in 13 patients with CIEDs in normal operating mode. Electrocardiography tracings, cardiovascular complications, tumor size, tumor-to-CIED distance, and tumor-to-device lead distance were recorded. Mean tumor size was 2.9 cm, mean tumor-to-CIED distance was 26.4 cm (range, 9-30 cm), and mean tumor-to-lead distance was 12.1 cm (range, 3.5-20 cm). No device-based cardiovascular complications or class C or higher complications per Society of Interventional Radiology criteria were identified. MW ablation appears to be safe in select patients with CIEDs.