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1.
Int J Hyperthermia ; 41(1): 2369305, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38897626

RESUMEN

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.


Asunto(s)
Intestino Delgado , Animales , Porcinos , Gases
3.
Radiol Imaging Cancer ; 6(2): e230080, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38334471

RESUMEN

Purpose To determine if microwave ablation (MWA) of retroperitoneal tumors can safely provide high rates of local tumor control. Materials and Methods This retrospective study included 19 patients (median age, 65 years [range = 46-78 years]; 13 [68.4%] men and six [31.6%] women) with 29 retroperitoneal tumors treated over 22 MWA procedures. Hydrodissection (0.9% saline with 2% iohexol) was injected in 17 of 22 (77.3%) procedures to protect nontarget anatomy. The primary outcomes evaluated were local tumor progression (LTP) and complication rates. Oncologic outcomes, including overall survival (OS), progression-free survival (PFS), and treatment-free interval (TFI), were examined as secondary outcome measures. Results Median follow-up was 18 months (range = 0.5-113). Hydrodissection was successful in displacing nontarget anatomy in 16 of 17 (94.1%) procedures. The LTP rate was 3.4% (one of 29; 95% CI: 0.1, 17.8) per tumor and 5.3% (one of 19; 95% CI: 0.1, 26.0) per patient. The overall complication rate per patient was 15.8% (three of 19), including two minor complications and one major complication. The OS rate at 1, 2, and 3 years was 81.8%, 81.8%, and 72.7%, respectively, with a median OS estimated at greater than 7 years. There was no evidence of a difference in OS (P = .34) and PFS (P = .56) between patients with renal cell carcinoma (six of 19 [31.6%]) versus other tumors (13 of 19 [68.4%]) and patients treated with no evidence of disease (15 of 22 [68.2%]) versus patients with residual tumors (seven of 22 [31.8%]). Median TFI was 18 months (range = 0.5-108). Conclusion Treatment of retroperitoneal tumors with MWA combined with hydrodissection provided high rates of local control, prolonged systemic therapy-free intervals, and few serious complications. Keywords: Ablation Techniques (ie, Radiofrequency, Thermal, Chemical), Retroperitoneum, Microwave Ablation, Hydrodissection © RSNA, 2024.


Asunto(s)
Neoplasias Renales , Neoplasias Retroperitoneales , Masculino , Humanos , Femenino , Persona de Mediana Edad , Anciano , Neoplasias Retroperitoneales/diagnóstico por imagen , Neoplasias Retroperitoneales/radioterapia , Neoplasias Retroperitoneales/cirugía , Resultado del Tratamiento , Microondas/uso terapéutico , Estudios Retrospectivos , Neoplasias Renales/diagnóstico por imagen , Neoplasias Renales/cirugía
4.
Tech Vasc Interv Radiol ; 26(3): 100911, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38071032

RESUMEN

CT navigation (CTN) has recently been developed to combine many of the advantages of conventional CT and CT-fluoroscopic guidance for needle placement. CTN systems display real-time needle position superimposed on a CT dataset. This is accomplished by placing electromagnetic (EM) or optical transmitters/sensors on the patient and needle, combined with fiducials placed within the scan field to superimpose a known needle location onto a CT dataset. Advantages of CTN include real-time needle tracking using a contemporaneous CT dataset with the patient in the treatment position, reduced radiation to the physician, facilitation of procedures outside the gantry plane, fewer helical scans during needle placement, and needle guidance based on diagnostic-quality CT datasets. Limitations include the display of a virtual (vs actual) needle position, which can be inaccurate if the needle bends, the fiducial moves, or patient movement occurs between scans, and limitations in anatomical regions with a high degree of motion such as the lung bases. This review summarizes recently introduced CTN technologies in comparison to historical methods of CT needle guidance. A "How I do it" section follows, which describes how CT navigation has been integrated into the study center for both routine and challenging procedures, and includes step-by-step explanations, technical tips, and pitfalls.


Asunto(s)
Cirugía Asistida por Computador , Tomografía Computarizada por Rayos X , Humanos , Fenómenos Electromagnéticos , Cirugía Asistida por Computador/métodos
5.
J Vasc Interv Radiol ; 2023 Nov 24.
Artículo en Inglés | MEDLINE | ID: mdl-38008378

RESUMEN

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.

6.
Int J Hyperthermia ; 40(1): 2272065, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37875279

RESUMEN

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.


Asunto(s)
Ultrasonido Enfocado de Alta Intensidad de Ablación , Neoplasias , Animales , Humanos , Ultrasonido Enfocado de Alta Intensidad de Ablación/métodos , Hígado/cirugía , Neoplasias/terapia , Modelos Animales , Riñón
7.
J Vasc Interv Radiol ; 34(11): 1986-1996, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37481064

RESUMEN

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.


Asunto(s)
Criocirugía , Neoplasias Renales , Humanos , Porcinos , Femenino , Animales , Criocirugía/efectos adversos , Criocirugía/métodos , Riñón/patología , Neoplasias Renales/patología , Tomografía Computarizada por Rayos X , Hemorragia Gastrointestinal/etiología , Resultado del Tratamiento
8.
J Vasc Interv Radiol ; 34(5): 910-918, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36736821

RESUMEN

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.


Asunto(s)
Fenómenos Electromagnéticos , Tomografía Computarizada por Rayos X , Humanos , Anciano , Estudios Retrospectivos , Biopsia , Tomografía Computarizada por Rayos X/efectos adversos , Tomografía Computarizada por Rayos X/métodos , Abdomen , Pelvis , Fluoroscopía
9.
Cancers (Basel) ; 15(3)2023 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-36765700

RESUMEN

Osteosarcoma (OS) is a malignant bone tumor treated by limb amputation or limb salvage surgeries and chemotherapy. Histotripsy is a non-thermal, non-invasive focused ultrasound therapy using controlled acoustic cavitation to mechanically disintegrate tissue. Recent ex vivo and in vivo pilot studies have demonstrated the ability of histotripsy for ablating OS but were limited in scope. This study expands on these initial findings to more fully characterize the effects of histotripsy for bone tumors, particularly in tumors with different compositions. A prototype 500 kHz histotripsy system was used to treat ten dogs with suspected OS at an intermediate treatment dose of 1000 pulses per location. One day after histotripsy, treated tumors were resected via limb amputation, and radiologic and histopathologic analyses were conducted to determine the effects of histotripsy for each patient. The results of this study demonstrated that histotripsy ablation is safe and feasible in canine patients with spontaneous OS, while offering new insights into the characteristics of the achieved ablation zone. More extensive tissue destruction was observed after histotripsy compared to that in previous reports, and radiographic changes in tumor size and contrast uptake following histotripsy were reported for the first time. Overall, this study significantly expands our understanding of histotripsy bone tumor ablation and informs future studies for this application.

10.
J Vasc Interv Radiol ; 34(3): 386-394.e2, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36503074

RESUMEN

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.


Asunto(s)
Ultrasonido Enfocado de Alta Intensidad de Ablación , Hígado , Porcinos , Animales , Riñón , Hemorragia/etiología , Ultrasonido Enfocado de Alta Intensidad de Ablación/efectos adversos , Anticoagulantes
11.
Cardiovasc Intervent Radiol ; 46(1): 120-127, 2023 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-36097074

RESUMEN

PURPOSE: This study was designed to evaluate the feasibility and safety of histotripsy subcutaneous (SQ) fat treatment in an in-vivo porcine model, and evaluate evolution of the treated volume on MRI and pathology. METHODS/MATERIALS: 10 histotripsy SQ fat treatments were completed in 5 swine, divided into four groups based on pre-determined survival: day 0 (n = 4), day 7 (n = 2), day 28 (n = 2), and day 56 (n = 2). A 4.0 × 4.0x2.0 cm ovoid treatment was created in the fat pad of the posterior thorax. MRI of survived animals were obtained on day 7 (n = 6), day 28 (n = 4), and day 56 (n = 2), and reviewed for size and imaging characteristics. Technical success was defined as the creation of a treatment zone in the targeted SQ fat. Skin firmness and indentation were qualitatively scored. RESULTS: Histotripsy had a 100% (10/10) technical success for creation of SQ fat treatments. Mean treatment time was 35.5 min (range 35-36.5). The volume of treated SQ fat demonstrated 92% volume reduction over the study. Day 0 gross pathology treatment had a mean volume of 12.6 cm3 (± 2.1) (prescribed volume of 16.7 cm3), which decreased to 8.3 cm3 (± 2.8) by day 7 (34% overall decrease), 3.0 cm3 (± 0.5) by day 28 (76% overall decrease), and 1.0 cm3 (± 1.2) by day 56 (92% overall decrease). Mean firmness and indentation scores showed no change from baseline at all time points, with no overlying skin injury. CONCLUSION: Histotripsy safely and effectively treated SQ fat of an in-vivo porcine model, with volume reduction over time.


Asunto(s)
Ultrasonido Enfocado de Alta Intensidad de Ablación , Porcinos , Animales , Ultrasonido Enfocado de Alta Intensidad de Ablación/métodos , Imagen por Resonancia Magnética , Grasa Subcutánea/diagnóstico por imagen
12.
IEEE Trans Biomed Eng ; 70(3): 768-779, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36006886

RESUMEN

INTRODUCTION: Histotripsy is a non-invasive focused ultrasound therapy that uses controlled acoustic cavitation to mechanically disintegrate tissue. To date, there are no reports investigating histotripsy for the treatment of soft tissue sarcoma (STS). OBJECTIVE: This study aimed to investigate the in vivo feasibility of ablating STS with histotripsy and to characterize the impact of partial histotripsy ablation on the acute immunologic response in canine patients with spontaneous STS. METHODS: A custom 500 kHz histotripsy system was used to treat ten dogs with naturally occurring STS. Four to six days after histotripsy, tumors were surgically resected. Safety was determined by monitoring vital signs during treatment and post-treatment physical examinations, routine lab work, and owners' reports. Ablation was characterized using radiologic and histopathologic analyses. Systemic immunological impact was evaluated by measuring changes in cytokine concentrations, and tumor microenvironment changes were evaluated by characterizing changes in infiltration with tumor-associated macrophages (TAMs) and tumor-infiltrating lymphocytes (TILs) using multiplex immunohistochemistry and differential gene expression. RESULTS: Results showed histotripsy ablation was achievable and well-tolerated in all ten dogs. Immunological results showed histotripsy induced pro-inflammatory changes in the tumor microenvironment. Conclusion & Significance: Overall, this study demonstrates histotripsy's potential as a precise, non-invasive treatment for STS.


Asunto(s)
Ultrasonido Enfocado de Alta Intensidad de Ablación , Sarcoma , Perros , Animales , Ultrasonido Enfocado de Alta Intensidad de Ablación/métodos , Sarcoma/diagnóstico por imagen , Sarcoma/terapia , Microambiente Tumoral
13.
Eur Radiol ; 33(2): 1050-1062, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36048208

RESUMEN

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.


Asunto(s)
Técnicas de Ablación , Ablación por Catéter , Ablación por Radiofrecuencia , Porcinos , Animales , Microondas/uso terapéutico , Hígado/diagnóstico por imagen , Hígado/cirugía , Hígado/irrigación sanguínea , Técnicas de Ablación/métodos , Vena Porta/cirugía , Ablación por Catéter/métodos
14.
Fed Pract ; 39(Suppl 2): S32-S36, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-35929010

RESUMEN

Background: Psychosocial barriers, including low socioeconomic status, homelessness, alcohol and substance use disorders, and psychiatric disorders are prevalent in US veterans. Our study aims to identify the prevalence of psychosocial barriers in veterans diagnosed with hepatocellular carcinoma (HCC), and their impact on receipt of cancer care. Methods: A retrospective cohort study was performed of all veterans diagnosed with HCC at the William S. Middleton Memorial Veterans' Hospital in Madison, Wisconsin, whose tumor care was coordinated through a multidisciplinary tumor board. Outcomes included receipt of any HCC-specific therapy and overall survival. Results: From January 1, 2007, through December 31, 2016, 149 veterans were diagnosed with HCC. Substance use disorders were reported in 124 (83%) patients, psychiatric illness was documented in 55 (37%) patients, 23 (15%) patients had incomes below the poverty threshold, and 7 (5%) were experiencing homelessness. The mean (SD) distance traveled for care was 207.1 (277.9) km; travel and lodging assistance were accessed by 50 (34%) and 33 (22%) veterans, respectively. Seventy-one patients (48%) had HCC exceeding T2 stage at diagnosis. Curative treatment was offered to 78 (52%) patients, with 127 (85%) receiving any HCC-specific care. Median survival from diagnosis was 727 days (95% CI, 488-966). Conclusions: Psychosocial barriers were common in our veteran cohort. Individualizing care, and coordination of travel and lodging, assisted in enabling high rates of receipt of HCC-specific therapy and improving patient survival.

15.
Int J Hyperthermia ; 39(1): 1115-1123, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36002243

RESUMEN

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.


Asunto(s)
Carcinoma Hepatocelular , Ultrasonido Enfocado de Alta Intensidad de Ablación , Neoplasias Hepáticas , Carcinoma Hepatocelular/etiología , Estudios de Factibilidad , Ultrasonido Enfocado de Alta Intensidad de Ablación/métodos , Humanos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/etiología , Neoplasias Hepáticas/terapia , Persona de Mediana Edad
16.
J Vasc Interv Radiol ; 33(9): 1045-1053, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35667580

RESUMEN

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.


Asunto(s)
Carcinoma Hepatocelular , Ablación por Catéter , Enfermedad Hepática en Estado Terminal , Neoplasias Hepáticas , Trasplante de Hígado , Carcinoma Hepatocelular/diagnóstico por imagen , Carcinoma Hepatocelular/patología , Carcinoma Hepatocelular/cirugía , Ablación por Catéter/efectos adversos , Femenino , Humanos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/cirugía , Trasplante de Hígado/métodos , Masculino , Microondas/efectos adversos , Persona de Mediana Edad , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
17.
Abdom Radiol (NY) ; 47(6): 2230-2237, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-35238963

RESUMEN

OBJECTIVE: To compare image quality and radiation dose between single-bolus 2-phase and split-bolus 1-phase CT Urography (CTU) performed immediately after microwave ablation (MWA) of clinically localized T1 (cT1) RCC. METHODS: Forty-two consecutive patients (30 M, mean age 67.5 ± 9.0) with cT1 RCC were treated with MWA from 7/2013 to 12/2013 at two academic quaternary-care institutions. Renal parenchymal enhancement, collecting system opacification and distention and size-specific dose estimate (SSDE) were quantified and image quality subjectively assessed on single-bolus 2-phase versus split-bolus 1-phase CTU. Kruskal-Wallis and Pearson's Chi-squared tests were performed to assess differences in continuous and categorical variables, respectively. Two-sample T test with equal variances was used to determine differences in quantitative and qualitative image data. RESULTS: Median tumor diameter was larger [2.9 cm (IQR 1.7-5.3) vs 3.6 cm (IQR 1.7-5.7), p = 0.01] in the split-bolus cohort. Mean abdominal girth (p = 0.20) was similar. Number of antennas used and unenhanced CTs obtained before and during MWA were similar (p = 0.11-0.32). Renal pelvis opacification (2.5 vs 3.5, p < 0.001) and distention (4 mm vs 8 mm, p < 0.001) were improved and renal enhancement (Right: 127 HU vs 177 HU, p = 0.001; Left: 124 HU vs 185 HU, p < 0.001) was higher for the split-bolus CTU. Image quality was superior for split-bolus CTU (3.2 vs 4.0, p = 0.004). Mean SSDE for the split-bolus CTU was significantly lower [163.9 mGy (SD ± 73.9) vs 36.3 mGy (SD ± 7.7), p < 0.001]. CONCLUSION: Split-bolus CTU immediately after MWA of cT1 RCC offers higher image quality, improved opacification/distention of the collecting system and renal parenchymal enhancement at a lower radiation dose.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Exposición a la Radiación , Anciano , Carcinoma de Células Renales/diagnóstico por imagen , Carcinoma de Células Renales/cirugía , Medios de Contraste , Femenino , Humanos , Neoplasias Renales/diagnóstico por imagen , Neoplasias Renales/cirugía , Masculino , Microondas/uso terapéutico , Persona de Mediana Edad , Tomografía Computarizada por Rayos X/métodos , Urografía/métodos
19.
Abdom Radiol (NY) ; 47(8): 2658-2668, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-34731282

RESUMEN

PURPOSE: To evaluate utility of advanced CT techniques including HighlY constrained back-projection and dual-energy CT for intra- and post-procedure hepatic microwave ablation zone monitoring. METHODS: 8 hepatic microwave ablations were performed in 4 adult swine (5 min/65 W). Low-dose routine CECT and dual-energy CT images were obtained every 1 min during ablation. Images were reconstructed ± HYPR. Image quality and dose metrics were collected. 21 MWA were performed in 4 adult swine. Immediate post-procedure CECT was performed in the arterial, portal venous, and delayed phases using both routine and DECT imaging with full-dose weight-based IV contrast dosing. An additional 16 MWA were subsequently performed in 2 adult swine. Immediate post-procedure CT was performed with half-dose IV contrast using routine and DECT. 12 patients (10 M/2F, mean age 62.4 yrs) with 14 hepatic tumors (4 HCC, 10 metastatic lesions) treated with MWA were prospectively imaged with DECT 1 month post-procedure. 120 kV equivalent images were compared to DECT [51 keV, iodine material density]. Image quality and dose metrics were collected. RESULTS: Gas created during MWA led to high CNR in all intraprocedural CT datasets. Optimal CNRs were noted at 4 min with CNR 6.7, 15.5,15.9, and 21.5 on LD-CECT, LD-CECT + HYPR, DECT, and DECT + HYPR, respectively (p < 0.001). Image quality scores at 4 min were 1.8, 2.8, 2.4, and 3, respectively (p < 0.001). Mean radiation dose (CTDIvol) was eightfold higher for the DECT series. For swine, post-procedural DECT images (IMD/51 keV) showed improved CNR compared to routine CT at all time points with full and with reduced dose contrast (CNR 4.6, 3.2, and 1.5, respectively, at half-contrast dose, p < 0.001). For human subjects, the 51 keV and IMD images showed higher CNRs (5.8, 4.8 vs 4.0, p < 0.001) and SNRs (3.7, 5.9 vs 2.8). Ablation zone sharpness was improved with DECT (routine 3.0 ± 0.7, DECT 3.5 ± 0.5). Diagnostic confidence was higher with DECT (routine 2.3 ± 0.9, DECT 2.6 ± 0.8). Mean DLP for DECT was 905.7 ± 606 mGy-cm, CTDIvol 37.5 ± 21.2 mGy, and effective dose 13.6 ± 9.1 mSv, slightly higher than conventional CT series. CONCLUSION: Advanced CT techniques can improve CT image quality in peri-procedural hepatic microwave ablation zone evaluation.


Asunto(s)
Carcinoma Hepatocelular , Neoplasias Hepáticas , Adulto , Animales , Medios de Contraste , Estudios de Seguimiento , Humanos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/cirugía , Microondas/uso terapéutico , Persona de Mediana Edad , Dosis de Radiación , Porcinos , Tomografía Computarizada por Rayos X/métodos
20.
Abdom Radiol (NY) ; 47(8): 2647-2657, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-34687328

RESUMEN

PURPOSE: To evaluate the efficacy of percutaneous biopsy for diagnosing intrahepatic cholangiocarcinoma (IHCCA). METHODS: Retrospective review of biopsy and pathology databases from 2006 to 2019 yielded 112 patients (54F/58 M; mean age, 62.9 years; 27 cirrhotic) with IHCCA who underwent percutaneous biopsy. Data regarding the lesion, biopsy procedure technique, and diagnostic yield were collected. If biopsy was non-diagnostic or discordant with imaging, details of repeat biopsy or resection/explant were gathered. A control group of 100 consecutive patients (56F/44 M; mean age, 63 years, 5 cirrhotic) with focal liver lesions > 1 cm was similarly assessed. RESULTS: Mean IHCCA lesion size was 6.1 ± 3.6 cm, with dominant lesion sampled in 78% (vs. satellite in 22%). 95% (n = 106) were US guided and 96% were core biopsies (n = 108), typically 18G (n = 102, 91%), median 2 passes. 18 patients (16%) had discordant/ambiguous pathology results requiring repeat biopsy, with two patients requiring 3-4 total attempts. A 4.4% minor complication rate was seen. Mean time from initial biopsy to final diagnosis was 60 ± 120 days. Control group had mean lesion size of 2.9 ± 2.5 cm and showed a non-diagnostic rate of 3.3%, both significantly lower than that seen with CCA, with average time to diagnosis of 21 ± 28.8 days (p = 0.002, p = 0.001). CONCLUSION: IHCCA is associated with lower diagnostic yield at initial percutaneous biopsy, despite larger target lesion size. If a suspicious lesion yields a biopsy result discordant with imaging, the radiologist should recommend prompt repeat biopsy to prevent delay in diagnosis.


Asunto(s)
Colangiocarcinoma , Tomografía Computarizada por Rayos X , Biopsia con Aguja Gruesa , Colangiocarcinoma/diagnóstico por imagen , Humanos , Biopsia Guiada por Imagen/métodos , Cirrosis Hepática/etiología , Persona de Mediana Edad , Estudios Retrospectivos , Tomografía Computarizada por Rayos X/métodos
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