MRI grading for the prediction of prostate cancer aggressiveness.

OBJECTIVES: T o evaluate the value of multiparametric MRI (mpMRI) for the prediction of prostate cancer (PCA) aggressiveness. METHODS: In this single center cohort study, consecutive patients with histologically confirmed PCA were retrospectively enrolled. Four different ISUP grade groups (1, 2, 3, 4-5) were defined and fifty patients per group were included. Several clinical (age, PSA, PSAD, percentage of PCA infiltration) and mpMRI parameters (ADC value, signal increase on high b-value images, diameter, extraprostatic extension [EPE], cross-zonal growth) were evaluated and correlated within the four groups. Based on combined descriptors, MRI grading groups (mG1-mG3) were defined to predict PCA aggressiveness. RESULTS: In total, 200 patients (mean age 68 years, median PSA value 8.1 ng/ml) were analyzed. Between the four groups, statistically significant differences could be shown for age, PSA, PSAD, and for MRI parameters cross-zonal growth, high b-value signal increase, EPE, and ADC (p < 0.01). All examined parameters revealed a significant correlation with the histopathologic biopsy ISUP grade groups (p < 0.01), except PCA diameter (p = 0.09). A mixed linear model demonstrated the strongest prediction of the respective ISUP grade group for the MRI grading system (p < 0.01) compared to single parameters. CONCLUSIONS: MpMRI yields relevant pre-biopsy information about PCA aggressiveness. A combination of quantitative and qualitative parameters (MRI grading groups) provided the best prediction of the biopsy ISUP grade group and may improve clinical pathway and treatment planning, adding useful information beyond PI-RADS assessment category. Due to the high prevalence of higher grade PCA in patients within mG3, an early re-biopsy seems indicated in cases of negative or post-biopsy low-grade PCA. KEY POINTS: • MpMRI yields relevant pre-biopsy information about prostate cancer aggressiveness. • MRI grading in addition to PI-RADS classification seems to be helpful for a size independent early prediction of clinically significant PCA. • MRI grading groups may help urologists in clinical pathway and treatment planning, especially when to consider an early re-biopsy.

A time-driven activity-based costing approach of magnetic resonance-guided high-intensity focused ultrasound for cancer-induced bone pain.

OBJECTIVE: To determine resource consumption and total costs for providing magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) treatment to a patient with cancer-induced bone pain (CIBP). METHODS: We conducted a time-driven activity-based costing (TD-ABC) of MR-HIFU treatments for CIBP from a hospital perspective. A European care-pathway (including a macro-, meso-, and micro-level) was designed to incorporate the care-delivery value chain. Time estimates were obtained from medical records and from prospective direct observations. To calculate the capacity cost rate, data from the controlling department of a German university hospital were allocated to the modules of the care pathway. Best- and worst-case scenarios were calculated by applying lower and upper bounds of time measurements. RESULTS: The macro-level care pathway consisted of eight modules (i.e., outpatient consultations, pretreatment imaging, preparation, optimization, sonication, post-treatment, recovery, and anesthesia). The total cost of an MR-HIFU treatment amounted to €5147 per patient. Best- and worst-case scenarios yielded a total cost of €4092 and to €5876. According to cost categories, costs due to equipment accounted for 41% of total costs, followed by costs with personnel (32%), overhead (16%) and materials (11%). CONCLUSION: MR-HIFU is an emerging noninvasive treatment for alleviating CIBP, with increasing evidence on treatment efficacy. This costing study can support MR-HIFU reimbursement negotiations and facilitate the adoption of MR-HIFU as first-line treatment for CIBP. The present TD-ABC model creates the opportunity of benchmarking the provision of MR-HIFU to bone tumor.Key pointsMagnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) is an emerging noninvasive treatment modality for alleviating cancer-induced bone pain (CIBP).From a hospital perspective, the total cost of MR-HIFU amounted to €5147 per treatment.This time-driven activity-based costing model creates the opportunity of benchmarking the provision of MR-HIFU to bone tumor.

MRI targeted single fraction HDR Brachytherapy for localized Prostate Carcinoma: a feasibility study of focal radiation therapy (ProFocAL).

OBJECTIVES: The aim of the study was to establish the setup and workflow for delivering focal MRI-guided high-dose-rate (HDR) brachytherapy for prostate cancer (PCA) and to assess patient comfort and safety aspects of MRI-guided single-fraction HDR. METHODS: Patients with histologically proven focal low- to intermediate-risk PCA with a single PIRADS 4/5 lesion were treated with percutaneous interstitial HDR brachytherapy in a single fraction with a minimum dose for the gross tumor volume of 20 Gy while sparing the organ at risk (OAR). Using a 3T-MRI, brachytherapy catheters were placed transgluteal in freehand technique. No antibiotic therapy or general analgesics were administered. Patient data, procedure time, patient discomfort, and complications were recorded. Quarterly PSA controls, biannual follow-up imaging, and annual re-biopsy were planned. RESULTS: So far, 9 patients were successfully treated and followed for 6 months. Mean intervention time was 34 min. Using the VAS scale, the pain reported for the intervention ranged from 2 to 3. Short-term follow-up showed no acute genitourinary or gastrointestinal toxicity so far. None of the patients displayed signs of infection. PSA levels in all patients decreased significantly. On follow up no residual PCA was detected treated region so far. PSA levels in all patients decreased significantly. On follow-up, no residual PCA was detected so far. CONCLUSIONS: MR-guided single-fraction focal HDR brachytherapy for localized PCA is feasible as well as safe for the individual patient. Catheters can be placed accurately and maximum therapeutic dose distribution can be restricted to the tumor. Countersigning the minimally invasive character of the procedure, no general anesthesia or antibiosis is necessary. KEY POINTS: • MR-guided focal HDR brachytherapy allows an accurate placement of catheters with maximum therapeutic dose distribution restricted to the tumor. • No major anesthesia or antibiosis is necessary emphasizing the minimal invasive character of the procedure. • Patients with low- and intermediate-risk prostate carcinoma in particular may benefit to halt disease progression whereas treatment-related morbidity is reduced compared with radical therapy.

Magnetic resonance imaging guided transatrial electrophysiological studies in swine using active catheter tracking - experience with 14 cases.

OBJECTIVES: To evaluate the feasibility of performing comprehensive Cardiac Magnetic resonance (CMR) guided electrophysiological (EP) interventions in a porcine model encompassing left atrial access. METHODS: After introduction of two femoral sheaths 14 swine (41 ± 3.6 kg) were transferred to a 1.5 T MR scanner. A three-dimensional whole-heart sequence was acquired followed by segmentation and the visualization of all heart chambers using an image-guidance platform. Two MR conditional catheters were inserted. The interventional protocol consisted of intubation of the coronary sinus, activation mapping, transseptal left atrial access (n = 4), generation of ablation lesions and eventually ablation of the atrioventricular (AV) node. For visualization of the catheter tip active tracking was used. Catheter positions were confirmed by passive real-time imaging. RESULTS: Total procedure time was 169 ± 51 minutes. The protocol could be completed in 12 swine. Two swine died from AV-ablation induced ventricular fibrillation. Catheters could be visualized and navigated under active tracking almost exclusively. The position of the catheter tips as visualized by active tracking could reliably be confirmed with passive catheter imaging. CONCLUSIONS: Comprehensive CMR-guided EP interventions including left atrial access are feasible in swine using active catheter tracking. KEY POINTS: • Comprehensive CMR-guided electrophysiological interventions including LA access were conducted in swine. • Active catheter-tracking allows efficient catheter navigation also in a transseptal approach. • More MR-conditional tools are needed to facilitate left atrial interventions in humans.

In vitro artefact assessment of a new MR-compatible microwave antenna and a standard MR-compatible radiofrequency ablation electrode for tumour ablation.

OBJECTIVE: To evaluate and compare artefact configuration and diameters in a magnetic resonance (MR)-compatible prototype microwave (MW) applicator and a standard MR-compatible radiofrequency (RF) applicator for MR-guided tumour ablation. METHODS: Both applicators were tested in a phantom study at 1.5T with three sequences: T1-weighted three-dimensional volume interpolated breath-hold examination (VIBE), T1-weighted fast low angle shot (FLASH), T2-weighted turbo spin echo (TSE). Applicator orientation to main magnetic field (B0) and slice orientation were varied. Needle tip location error (TLE) was assessed, and artefact diameters were calculated. Influence of imaging parameters on artefacts was assessed with analysis of variance (ANOVA) and post hoc testing. RESULTS: MW applicator: the shaft artefact diameter measured 2.3 +/- 0.8 mm. Tip artefact diameter and length measured 2.2 ± 0.8 mm and 2.4 ± 1.3 mm, respectively. A prominent oval artefact (diameter: 16.5 +/- 1.8 mm, length: 19.1 +/- 2.5 mm) appeared close to the tip. TLE: - .3 +/- 0.6 mm. RF applicator: shaft and tip diameter measured 8.9 +/- 4.7 mm and 9.0 +/- .0 mm, respectively. TLE: -0.1 +/- 0.8 mm. Minimal artefacts were measured with RF applicator orientation parallel to B0 (P < 0.0001), whereas no such influence was found for MW applicator. For both applicators, significantly large artefacts were measured with T1 FLASH (P = 0.03). CONCLUSION: The MW applicator's artefact is satisfactory and seems useable for MR-guided ablation procedures. KEY POINTS: MW applicator's artefact appearance is independent of angulation to main magnetic field. MW applicator's prominent distal artefact may increase visibility under MR-guidance. RF and MW applicator's artefacts are precise concerning tip depiction. Largest artefact diameters are measured with T1-weighted fast low angle shot sequence.

Accuracy of 3D real-time MRI temperature mapping in gel phantoms during microwave heating.

BACKGROUND: Interventional magnetic resonance imaging (MRI) can provide a comprehensive setting for microwave ablation of tumors with real-time monitoring of the energy delivery using MRI-based temperature mapping. The purpose of this study was to quantify the accuracy of three-dimensional (3D) real-time MRI temperature mapping during microwave heating in vitro by comparing MRI thermometry data to reference data measured by fiber-optical thermometry. METHODS: Nine phantom experiments were evaluated in agar-based gel phantoms using an in-room MR-conditional microwave system and MRI thermometry. MRI measurements were performed for 700 s (25 slices; temporal resolution 2 s). The temperature was monitored with two fiber-optical temperature sensors approximately 5 mm and 10 mm distant from the microwave antenna. Temperature curves of the sensors were compared to MRI temperature data of single-voxel regions of interest (ROIs) at the sensor tips; the accuracy of MRI thermometry was assessed as the root-mean-squared (RMS)-averaged temperature difference. Eighteen neighboring voxels around the original ROI were also evaluated and the voxel with the smallest temperature difference was additionally selected for further evaluation. RESULTS: The maximum temperature changes measured by the fiber-optical sensors ranged from 7.3 K to 50.7 K. The median RMS-averaged temperature differences in the originally selected voxels ranged from 1.4 K to 3.4 K. When evaluating the minimum-difference voxel from the neighborhood, the temperature differences ranged from 0.5 K to 0.9 K. The microwave antenna and the MRI-conditional in-room microwave generator did not induce relevant radiofrequency artifacts. CONCLUSION: Accurate 3D real-time MRI temperature mapping during microwave heating with very low RMS-averaged temperature errors below 1 K is feasible in gel phantoms. RELEVANCE STATEMENT: Accurate MRI-based volumetric real-time monitoring of temperature distribution and thermal dose is highly relevant in clinical MRI-based interventions and can be expected to improve local tumor control, as well as procedural safety by extending the limits of thermal (e.g., microwave) ablation of tumors in the liver and in other organs. KEY POINTS: Interventional MRI can provide a comprehensive setting for the microwave ablation of tumors. MRI can monitor the microwave ablation using real-time MRI-based temperature mapping. 3D real-time MRI temperature mapping during microwave heating is feasible. Measured temperature errors were below 1 °C in gel phantoms. The active in-room microwave generator did not induce any relevant radiofrequency artifacts.

Multiparametric Magnetic Resonance Imaging in Prostate Cancer Screening at the Age of 45 Years: Results from the First Screening Round of the PROBASE Trial.

BACKGROUND: Magnetic resonance imaging (MRI) has been suggested as a tool for guiding biopsy recommendations in prostate cancer (PC) screening. OBJECTIVE: To determine the performance of multiparametric MRI (mpMRI) in young men at age 45 yr who participated in a PC screening trial (PROBASE) on the basis of baseline prostate-specific antigen (PSA). DESIGN, SETTING, AND PARTICIPANTS: Participants with confirmed PSA ≥3 ng/ml were offered mpMRI followed by MRI/transrectal ultrasound fusion biopsy (FBx) with targeted and systematic cores. mpMRI scans from the first screening round for men randomised to an immediate PSA test in PROBASE were evaluated by local readers and then by two reference radiologists (experience >10 000 prostate MRI examinations) blinded to the histopathology. The PROBASE trial is registered as ISRCTN37591328 OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The local and reference Prostate Imaging-Data and Reporting System (PI-RADS) scores were compared, and the sensitivity, negative predictive value (NPV), and accuracy were calculated for both readings for different cutoffs (PI-RADS 3 vs 4). RESULTS AND LIMITATIONS: Of 186 participants, 114 underwent mpMRI and FBx. PC was detected in 47 (41%), of whom 33 (29%) had clinically significant PC (csPC; International Society of Urological Pathology grade group ≥2). Interobserver reliability between local and reference PI-RADS scores was moderate (k = 0.41). At a cutoff of PI-RADS 4, reference reading showed better performance for csPC detection (sensitivity 79%, NPV 91%, accuracy of 85%) than local reading (sensitivity 55%, NPV 80%, accuracy 68%). Reference reading did not miss any PC cases for a cutoff of PI-RADS <3. If PI-RADS ≥4 were to be used as a biopsy cutoff, mpMRI would reduce negative biopsies by 68% and avoid detection of nonsignificant PC in 71% of cases. CONCLUSIONS: Prostate MRI in a young screening population is difficult to read. The MRI accuracy of for csPC detection is highly dependent on reader experience, and double reading might be advisable. More data are needed before MRI is included in PC screening for men at age 45 yr. PATIENT SUMMARY: Measurement of prostate specific antigen (PSA) is an effective screening test for early detection of prostate cancer (PC) and can reduce PC-specific deaths, but it can also lead to unnecessary biopsies and treatment. Magnetic resonance imaging (MRI) after a positive PSA test has been proposed as a way to reduce the number of biopsies, with biopsy only recommended for men with suspicious MRI findings. Our results indicate that MRI accuracy is moderate for men aged 45 years but can be increased by a second reading of the images by expert radiologists. For broad application of MRI in routine screening, double reading may be advisable.

Evaluation of MR-safe bioptomes for MR-guided endomyocardial biopsy in minipigs: a potential radiation-free clinical approach.

BACKGROUND: Diagnostic accuracy of endomyocardial biopsy could improve if clinically safe magnetic resonance (MR)-compatible bioptomes were available. We explored two novel MR-compatible cardiac bioptomes for performance, safety, and clinical viability, employing in vivo minipig trials and phase-contrast synchrotron radiation computed microtomography (SRµCT). METHODS: Analysis of ex vivo obtained pig endomyocardial biopsies was performed using phase-contrast SRµCT and conventional two-dimensional histology. The technical performance was evaluated by measuring volume, inner and outer integrities, compression, and histological diagnostic value in 3 sets (6 per set) of biopsies for each experimental bioptome. The bioptomes were tested in vivo in 3 healthy minipigs per bioptome. The clinical feasibility was evaluated by procedural and cutting success as well as histological diagnostic value. RESULTS: The bioptome with the 'grind-grind' design achieved similar values to control in compression (p = 0.822), inner (p = 0.628), and outer (p = 0.507), integrities ex vivo. It showed a better performance in the in vivo real-time MRI setting demonstrating a higher cutting success (91.7%) than the 'grind-anvil' (86.2%) design. In both ex vivo and in vivo evaluations, the 'grind-grind' design displayed sufficient diagnostic value (83% and 95%). The 'grind-anvil' design showed adequate diagnostic value both ex vivo and in vivo (78% and 87.5%) but was not comparable to control according to the three-dimensional (3D) analysis. CONCLUSION: A novel MR-compatible bioptome was identified as plausible in a clinical setting. Additionally, SRµCT and subsequent 3D structural analysis could be valuable in the label-free investigation of myocardial tissue at a micrometer level. RELEVANCE STATEMENT: Implementation of MR-guided biopsy can improve animal studies on structural myocardial changes at any point in an experimental setup. With further improvements in guiding catheters, MR-guided biopsy, using the new bioptome, has a potential to increase quality and diagnostic accuracy in patients both with structural and inflammatory cardiomyopathies. KEY POINTS: • Novel MR-compatible bioptomes show promise for a clinical application. • SRµCT enabled detailed analysis of endomyocardial biopsies. • The bioptomes showed adequate in vivo performance without major complications.

Neuroablative Intervention for Refractory Obsessive-Compulsive Disorder.

OBJECTIVE: This review aims to investigate the progression of neuroablation, along with documented clinical efficacy and safety, in the management of treatment-resistant obsessive-compulsive disorder (OCD). METHODS: We searched and compiled clinical research results of neuroablation therapy reported to date. We extracted outcomes related to clinical efficacy, side effects, and surgical complications. Additionally, we summarized key claims and findings. RESULTS: Neuroablative intervention is a potential treatment approach for refractory OCD. Recent advancements, such as real-time magnetic resonance monitoring and minimally invasive techniques employing ultrasound and laser, offer distinct advantages in terms of safety and comparative efficacy when compared to conventional methods. However, the absence of randomized controlled trials and long-term outcome data underscores the need for cautious consideration when selecting neuroablation. CONCLUSION: Neuroablative intervention shows promise for refractory OCD, but vigilant consideration is essential in both patient selection and surgical method choices due to the potential for rare yet serious complications.

Impact of dynamic contrast-enhanced MRI in 1.5 T versus 3 T MRI for clinically significant prostate cancer detection.

PURPOSE: This study analyzes the value of dynamic contrast-enhanced MRI (DCE) of the prostate on 1.5 T and 3 T examinations in patients within PI-RADS category 4. METHODS: In this retrospective, bi-centric, cohort study all consecutive patients classified as PI-RADS 4 in mpMRI with 100 verified prostate cancers (PCa) in subsequent MRI/US-guided fusion biopsy were included for 1.5 T and 3 T, each. PCa detection in index lesions (IL) upgraded to PI-RADS 4 based on positive DCE findings was compared between 1.5 T and 3 T. Secondary objectives are subgroup analysis of PZ lesions and comparison of ISUP grade group distribution between 1.5 T and 3 T. RESULTS: In total, 293 patients within PI-RADS category 4, including 152 (mean 66 ± 8y; median PSA 6.4 ng/ml;116 PZ IL) in the 1.5 T group and 141 (mean 65 ± 8y; median PSA 7.2 ng/ml;100 PZ IL) in the 3 T group were included. Overall amount of PCa (66 % vs 71 %; p = 0.346) and portion of upgraded IL (28 % vs 21 %; p = 0.126) did not differ significantly. At 1.5 T PCa detection was higher in upgraded PZ lesions compared to 3 T (23 % vs 14 %; p = 0.048). The amount of upgraded PZ lesions with ISUP grade group 2-5 PCa was significantly higher at 1.5 T versus 3 T (13.8 % vs 4.0 %; p = 0.007). 33 % (11/33; 1.5 T) and 32 % (10/31; 3 T) of the ISUP grade group 1 PCa of the PZ lesions were detected in upgraded lesions (10% of all PZ index lesions, respectively). CONCLUSION: DCE enabled the detection of a substantial amount of additional clinically significant PCa in prostate mpMRI at 1.5 T. The effect was smaller at 3 T and was accompanied in relation to 1.5 T by higher risk of overdiagnosis due to detection of additional low-risk PCa.

Comparison of 3 T mpMRI and pelvic CT examinations for detection of lymph node metastases in patients with prostate cancer.

PURPOSE: This study investigates preoperative lymph node metastases (LNM) detection accuracy by MRI and CT in patients with prostate cancer (PCA). METHODS: All patients with preoperative MRI, CT or both and subsequent radical prostatectomy (RPE) and lymphadenectomy (LA) were included in this retrospective cohort study. Prostate specific antigen (PSA), PI-RADS, ISUP grade group, clinical and pathological tumor (T) stage was compared between negative and positive nodal (N) stage. LNM were assessed with size and localization and weather they were preoperatively detected or not. In patients with preoperative CT and MRI, the results were compared intermodally. The reference standard was the histopathological results after RPE and LA. RESULTS: A total of 228 patients were analysed including 24 patients with confirmed LNM (N1; 11%). PSA (median 9.7 vs. 14 ng/ml), PI-RADS (median 4 vs. 5), ISUP (median 2 vs. 4), and cT/pT-stage (median T2 vs. T3) was significantly higher in patients with LNM. No LNM were found in patients with ISUP-1-PCA. MRI was able to detect 67% of patients with LNM. Lymph node metastases presented on MRI predominantly small, round-shaped, located parailiacally with a minimum SAD of 4 mm (vs. CT SAD of 8 mm). In comparison, MRI was superior to CT in the detection of LNM (sensitivity 81% vs. 33%; specificity 99% vs. 97). CONCLUSION: LNM were very rare in patients with PSA < 10 ng/ml, PI-RADS ≤ 4, and ≤ cT2. MRI could detect LNM up to 4 mm with a moderate sensitivity and high specificity. Thus, MRI might optimise the preoperative diagnostic and therapy planning of patients with PCA, whereas CT was clearly limited for N-stage assessment.

Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial.

BACKGROUND: Cancer-induced bone pain (CIBP), caused by bone metastases, is a common complication of cancer and strongly impairs quality of life (QoL). External beam radiotherapy (EBRT) is the current standard of care for treatment of CIBP. However, approximately 45% of patients have no adequate pain response after EBRT. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) may improve pain palliation in this patient population. The main objective of this trial was to compare MR-HIFU, EBRT, and MR-HIFU + EBRT for the palliative treatment of bone metastases. METHODS/DESIGN: The FURTHER trial is an international multicenter, three-armed randomized controlled trial. A total of 216 patients with painful bone metastases will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or combined treatment with EBRT followed by MR-HIFU. During a follow-up period of 6 months, patients will be contacted at eight time points to retrieve information about their level of pain, QoL, and the occurrence of (serious) adverse events. The primary outcome of the trial is pain response at 14 days after start of treatment. Secondary outcomes include pain response at 14 days after trial enrolment, pain scores (daily until the 21st day and at 4, 6, 12 and 24 weeks), toxicity, adverse events, QoL, and survival. Cost-effectiveness and cost-utility analysis will be conducted. DISCUSSION: The FURTHER trial aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU-alone or in combination with EBRT-compared to EBRT to relieve CIBP. The trial will be performed in six hospitals in four European countries, all of which are partners in the FURTHER consortium. TRIAL REGISTRATION: The FURTHER trial is registered under the Netherlands Trials Register number NL71303.041.19 and ClinicalTrials.gov registration number NCT04307914. Date of trial registration is 13-01-2020.

Comparison of (Cost-)Effectiveness of Magnetic Resonance Image-Guided High-Intensity-Focused Ultrasound With Standard (Minimally) Invasive Fibroid Treatments: Protocol for a Multicenter Randomized Controlled Trial (MYCHOICE).

BACKGROUND: Magnetic resonance image-guided high-intensity-focused ultrasound (MR-HIFU) is a rather new, noninvasive option for the treatment of uterine fibroids. It is safe, effective, and has a very short recovery time. However, a lack of prospectively collected data on long-term (cost-)effectiveness of the MR-HIFU treatment compared with standard uterine fibroid care prevents the MR-HIFU treatment from being reimbursed for this indication. Therefore, at this point, when conservative treatment for uterine fibroid symptoms has failed or is not accepted by patients, standard care includes the more invasive treatments hysterectomy, myomectomy, and uterine artery embolization (UAE). Primary outcomes of currently available data on MR-HIFU treatment often consist of technical outcomes, instead of patient-centered outcomes such as quality of life (QoL), and do not include the use of the latest equipment or most up-to-date treatment strategies. Moreover, data on cost-effectiveness are rare and seldom include data on a societal level such as productivity loss or use of painkillers. Because of the lack of reimbursement, broad clinical implementation has not taken place, nor is the proper role of MR-HIFU in uterine fibroid care sufficiently clear. OBJECTIVE: The objective of our study is to determine the long-term (cost-)effectiveness of MR-HIFU compared with standard (minimally) invasive fibroid treatments. METHODS: The MYCHOICE study is a national, multicenter, open randomized controlled trial with randomization in a 2:1 ratio to MR-HIFU or standard care including hysterectomy, myomectomy, and UAE. The sample size is 240 patients in total. Women are included when they are 18 years or older, in premenopausal stage, diagnosed with symptomatic uterine fibroids, conservative treatment has failed or is not accepted, and eligible for MR-HIFU. Primary outcomes of the study are QoL 24 months after treatment and costs of treatment including direct health care costs, loss of productivity, and patient costs. RESULTS: Inclusion for the MYCHOICE study started in November 2020 and enrollment will continue until 2024. Data collection is expected to be completed in 2026. CONCLUSIONS: By collecting data on the long-term (cost-)effectiveness of the MR-HIFU treatment in comparison to current standard fibroid care, we provide currently unavailable evidence about the proper place of MR-HIFU in the fibroid treatment spectrum. This will also facilitate reimbursement and inclusion of MR-HIFU in (inter)national uterine fibroid care guidelines. TRIAL REGISTRATION: Netherlands Trial Register NL8863; https://www.trialregister.nl/trial/8863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29467.

Comparison and prediction of artefact severity due to total hip replacement in 1.5 T versus 3 T MRI of the prostate.

PURPOSE: To evaluate image quality and diagnostic value of multiparametric prostate MRI (mpMRI) in patients with total hip replacement (THR) at 1.5 and 3 Tesla. METHODS: In this retrospective multicenter cohort study patients with uni- or bilateral THR and 1.5 T or 3 T mpMRI were included. Seventy consecutive, standard-of-care examinations per field strength were evaluated regarding their diagnostic value. The overall diagnostic value and prostate imaging quality score (PI-QUAL) were assessed. Artifact severity in the localizer and mpMRI sequences (T2w, DWI, DCE) was scored on a 3-point scale. Correlation between diagnostic value and artifacts was analysed. Moreover, a subgroup analysis focussed on image quality at different 3 T scanner generations. RESULTS: 140 consecutive patients (mean age 72, median PSA value 8.3 ng/ml) were included. When comparing 1.5 T to 3 T examinations, no significant differences were observed regarding the artifact severity of DWI and the localizer and the overall diagnostic value of the images. There was a strong correlation between the diagnostic value, PI-QUAL score, and artifact severity in the localizer and DWI. T2w and DCE sequences showed overall low artifacts. Significant improvement in image quality for 3 T at the latest scanner generation was observed, especially for DWI (p < 0.03). CONCLUSIONS: MpMRI of patients with THR can be conducted at both field strengths without significant differences in artifacts. The localizer might be useful as an early forecasting feature for diagnostic value and particularly for contrast medium application decision. Patients with THR could benefit from technically advanced scanner generation and rs/ptx-EPI DWI sequences.

Combining radiotherapy and focused ultrasound for pain palliation of cancer induced bone pain; a stage I/IIa study according to the IDEAL framework.

BACKGROUND: Cancer induced bone pain (CIBP) strongly interferes with patient's quality of life. Currently, the standard of care includes external beam radiotherapy (EBRT), resulting in pain relief in approximately 60% of patients. Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) is a promising treatment modality for CIBP. METHODS: A single arm, R-IDEAL stage I/IIa study was conducted. Patients presenting at the department of radiation oncology with symptomatic bone metastases in the appendicular skeleton, as well as in the sacrum and sternum were eligible for inclusion. All participants underwent EBRT, followed by MR-HIFU within 4 days. Safety and feasibility were assessed, and pain scores were monitored for 4 weeks after completing the combined treatment. RESULTS: Six patients were enrolled. Median age was 67 years, median lesion diameter was 56,5 mm. In all patients it was logistically possible to plan and perform the MR-HIFU treatment within 4 days after EBRT. All patients tolerated the combined procedure well. Pain response was reported by 5 out of 6 patients at 7 days after completion of the combined treatment, and stabilized on 60% at 4 weeks follow up. No treatment related serious adverse events occurred. CONCLUSION: This is the first study to combine EBRT with MR-HIFU. Our results show that combined EBRT and MR-HIFU in first-line treatment of CIBP is safe and feasible, and is well tolerated by patients. Superiority over standard EBRT, in terms of (time to) pain relief and quality of life need to be evaluated in comparative (randomized) study.

Transcatheter Myocardial Needle Chemoablation During Real-Time Magnetic Resonance Imaging: A New Approach to Ablation Therapy for Rhythm Disorders.

BACKGROUND: Radiofrequency ablation for ventricular arrhythmias is limited by inability to visualize tissue destruction, by reversible conduction block resulting from edema surrounding lesions, and by insufficient lesion depth. We hypothesized that transcatheter needle injection of caustic agents doped with gadolinium contrast under real-time magnetic resonance imaging (MRI) could achieve deep, targeted, and irreversible myocardial ablation, which would be immediately visible. METHODS AND RESULTS: Under real-time MRI guidance, ethanol or acetic acid was injected into the myocardium of 8 swine using MRI-conspicuous needle catheters. Chemoablation lesions had identical geometry by in vivo and ex vivo MRI and histopathology, both immediately and after 12 (7-17) days. Ethanol caused stellate lesions with patchy areas of normal myocardium, whereas acetic acid caused homogeneous circumscribed lesions of irreversible necrosis. Ischemic cardiomyopathy was created in 10 additional swine by subselective transcoronary ethanol administration into noncontiguous territories. After 12 (8-15) days, real-time MRI-guided chemoablation-with 2 to 5 injections to create a linear lesion-successfully eliminated the isthmus and local abnormal voltage activities. CONCLUSIONS: Real-time MRI-guided chemoablation with acetic acid enabled the intended arrhythmic substrate, whether deep or superficial, to be visualized immediately and ablated irreversibly. In an animal model of ischemic cardiomyopathy, obliteration of a conductive isthmus both anatomically and functionally and abolition of local abnormal voltage activities in areas of heterogeneous scar were feasible. This represents the first report of MRI-guided myocardial chemoablation, an approach that could improve the efficacy of arrhythmic substrate ablation in the thick ventricular myocardium.

Fully percutaneous transthoracic left atrial entry and closure as a potential access route for transcatheter mitral valve interventions.

BACKGROUND: Percutaneous access for mitral interventions is currently limited to transapical and transseptal routes, both of which have shortcomings. We hypothesized that the left atrium could be accessed directly through the posterior chest wall under imaging guidance. METHODS AND RESULTS: We tested percutaneous transthoracic left atrial access in 12 animals (10 pigs and 2 sheep) under real-time magnetic resonance imaging or x-ray fluoroscopy plus C-arm computed tomographic guidance. The pleural space was insufflated with CO2 to displace the lung, an 18F sheath was delivered to the left atrium, and the left atrial port was closed using an off-the-shelf nitinol cardiac occluder. Animals were survived for a minimum of 7 days. The left atrial was accessed, and the port was closed successfully in 12/12 animals. There was no procedural mortality and only 1 hemodynamically insignificant pericardial effusion was observed at follow-up. We also successfully performed the procedure on 3 human cadavers. A simulated trajectory to the left atrium was present in all of 10 human cardiac computed tomographic angiograms analyzed. CONCLUSIONS: Percutaneous transthoracic left atrial access is feasible without instrumenting the left ventricular myocardium. In our experience, magnetic resonance imaging offers superb visualization of anatomic structures with the ability to monitor and address complications in real-time, although x-ray guidance seems feasible. Clinical translation seems realistic based on human cardiac computed tomographic analysis and cadaver testing. This technique could provide a direct nonsurgical access route for future transcatheter mitral implantation.