MRI-compatible abdomen phantom to mimic respiratory-triggered organ movement while performing needle-based interventions.

PURPOSE: In vivo studies are often required to prove the functionality and safety of medical devices. Clinical trials are costly and complex, adding to ethical scrutiny of animal testing. Anthropomorphic phantoms with versatile functionalities can overcome these issues with regard to medical education or an effective development of assistance systems during image-guided interventions (e.g., robotics, navigation/registration algorithms). In this work, an MRI-compatible and customizable motion phantom is presented to mimic respiratory-triggered organ movement as well as human anatomy. METHODS: For this purpose, polyvinyl alcohol cryogel (PVA-C) was the foundation for muscles, liver, kidneys, tumors, and remaining abdominal tissue in different sizes of the abdominal phantom body (APB) with the ability to mimic human tissue in various properties. In addition, a semi-flexible rib cage was 3D-printed. The motion unit (MU) with an electromagnetically shielded stepper motor and mechanical extensions simulated a respiration pattern to move the APB. RESULTS: Each compartment of the APB complied the relaxation times, dielectricity, and elasticity of human tissue. It showed resistance against mold and provided a resealable behavior after needle punctures. During long-term storage, the APB had a weight loss of 2.3%, followed by changes to relaxation times of 9.3% and elasticity up to 79%. The MU was able to physiologically appropriately mimic the organ displacement without reducing the MRI quality. CONCLUSION: This work presents a novel modularizable and low-cost PVA-C based APB to mimic fundamental organ motion. Beside a further organ motion analysis, an optimization of APB's chemical composition is needed to ensure a realistic motion simulation and reproducible long-term use. This phantom enhances diverse and varied training environments for prospective physicians as well as effective R&D of medical devices with the possibility to reduce in vivo experiments.

A probabilistic thermal dose model for the estimation of necrosis in MR-guided tumor ablations.

BACKGROUND: Monitoring minimally invasive thermo ablation procedures using magnetic resonance (MR) thermometry allows therapy of tumors even close to critical anatomical structures. Unfortunately, intraoperative monitoring remains challenging due to the necessary accuracy and real-time capability. One reason for this is the statistical error introduced by MR measurement, which causes the prediction of ablation zones to become inaccurate. PURPOSE: In this work, we derive a probabilistic model for the prediction of ablation zones during thermal ablation procedures based on the thermal damage model CEM43 . By integrating the statistical error caused by MR measurement into the conventional prediction, we hope to reduce the amount of falsely classified voxels. METHODS: The probabilistic CEM43 model is empirically evaluated using a polyacrilamide gel phantom and three in-vivo pig livers. RESULTS: The results show a higher accuracy in three out of four data sets, with a relative difference in Sørensen-Dice coefficient from - 3.04 % $-3.04\%$ to 3.97% compared to the conventional model. Furthermore, the ablation zones predicted by the probabilistic model show a false positive rate with a relative decrease of 11.89%-30.04% compared to the conventional model. CONCLUSION: The presented probabilistic thermal dose model might help to prevent false classification of voxels within ablation zones. This could potentially result in an increased success rate for MR-guided thermal ablation procedures. Future work may address additional error sources and a follow-up study in a more realistic clinical context.

First experiences using transurethral ultrasound ablation (TULSA) as a promising focal approach to treat localized prostate cancer: a monocentric study.

PURPOSE: To share our experience using transurethral ultrasound ablation (TULSA) treatment for focal therapy of localized prostate cancer (PCa). MATERIALS AND METHODS: Between 10/2019 and 06/2021 TULSA treatment for localized PCa was performed in 22 men (mean age: 67 ± 7 years, mean initial PSA: 6.8 ± 2.1 ng/ml, ISUP 1 in n = 6, ISUP 2 in n = 14 and 2 patients with recurrence after previous radiotherapy). Patients were selected by an interdisciplinary team, taking clinical parameters, histopathology from targeted or systematic biopsies, mpMRI and patients preferences into consideration. Patients were thoroughly informed about alternative treatment options and that TULSA is an individual treatment approach. High-intensity ultrasound was applied using an ablation device placed in the prostatic urethra. Heat-development within the prostatic tissue was monitored using MR-thermometry. Challenges during the ablation procedure and follow-up of oncologic and functional outcome of at least 12 months after TULSA treatment were documented. RESULTS: No major adverse events were documented. In the 12 month follow-up period, no significant changes of urinary continence, irritative/obstructive voiding symptoms, bowel irritation or hormonal symptoms were reported according to the Expanded Prostate Cancer Index Composite (EPIC) score. Erectile function was significantly impaired 3-6 months (p < 0.01) and 9-12 months (p < 0.05) after TULSA. PSA values significantly decreased after therapy (2.1 ± 1.8 vs. 6.8 ± 2.1 ng/ml, p < 0.001). PCa recurrence rate was 23% (5/22 patients). CONCLUSION: Establishment of TULSA in clinical routine was unproblematic, short-term outcome seems to be encouraging. The risk of erectile function impairment requires elaborate information of the patient.

Free-breathing 3D Stack-of-Stars Gradient Echo Sequence in MR-guided Percutaneous Liver Interventions: Evaluation of Workflow and Diagnostic Quality.

PURPOSE: To evaluate workflow efficiency and diagnostic quality of a free-breathing 3D stack-of-stars gradient echo (Radial GRE) sequence compared to a breath-hold 3D Cartesian gradient echo (Cartesian GRE) sequence for needle position control in MR-guided liver interventions. MATERIALS AND METHODS: 12 MR-guided liver interventions were performed on a 1.5 T Siemens Aera and analyzed retrospectively. 15 series of the Radial GRE sequence were compared to 14 series of the Cartesian GRE sequence regarding the time interval between two consecutive live-scans for needle tracking (Tracking-2-Tracking-Time). The quality of both sequences was compared by the SNR within comparable slices in liver and tumor ROIs. The CNR was calculated by subtraction of the SNR values. Subjective image quality scores of three radiologists were assessed and inter-rater reliability was tested by Fleiss' kappa. Values are given as mean ± SD. P-values < 0.05 were considered as significant. RESULTS: The median Tracking-2-Tracking-Time was significantly shorter for the Radial GRE sequence, 185 ± 42 s vs. 212 ± 142 s (p = 0.04) and the median SNR of the liver and tumor ROIs were significantly higher in the Radial GRE sequence, 249 ± 92 vs. 109 ± 67 (p = 0.03) and 165 ± 74 vs. 77 ± 43 (p = 0.02). CNR between tumor and liver ROIs showed a tendency to be higher for the Radial GRE sequence without significance, 68 ± 48 vs. 49 ± 32 (p = 0.28). Mean subjective image quality was 3.33 ± 1.08 vs. 2.62 ± 0.95 comparing Radial and Cartesian GRE with a Fleiss' kappa of 0.39 representing fair inter-rater reliability. CONCLUSION: A free-breathing 3D stack-of-stars gradient echo sequence can simplify the workflow and reduce intervention time, while providing superior image quality. Under local anesthesia, it increases patient comfort and reduces potential risks for needle dislocations in MR-guided liver interventions by avoiding respiratory arrests for needle position control.

Adaptive simulation of 3D thermometry maps for interventional MR-guided tumor ablation using Pennes' bioheat equation and isotherms.

Minimally-invasive thermal ablation procedures have become clinically accepted treatment options for tumors and metastases. Continuous and reliable monitoring of volumetric heat distribution promises to be an important condition for successful outcomes. In this work, an adaptive bioheat transfer simulation of 3D thermometry maps is presented. Pennes' equation model is updated according to temperature maps generated by uniformly distributed 2D MR phase images rotated around the main axis of the applicator. The volumetric heat diffusion and the resulting shape of the ablation zone can be modelled accurately without introducing a specific heat source term. Filtering the temperature maps by extracting isotherms reduces artefacts and noise, compresses information of the measured data and adds physical a priori knowledge. The inverse heat transfer for estimating values of the simulated tissue and heating parameters is done by reducing the sum squared error between these isotherms and the 3D simulation. The approach is evaluated on data sets consisting of 13 ex vivo bio protein phantoms, including six perfusion phantoms with simulated heat sink effects. Results show an overall average Dice score of 0.89 ± 0.04 (SEM < 0.01). The optimization of the parameters takes 1.05 ± 0.26 s for each acquired image. Future steps should consider the local optimization of the simulation parameters instead of a global one to better detect heat sinks without a priori knowledge. In addition, the use of a proper Kalman filter might increase robustness and accuracy if combined with our method.

Correction of heat-induced susceptibility changes in respiratory-triggered 2D-PRF-based thermometry for monitoring of magnetic resonance-guided hepatic microwave ablation in a human-like in vivo porcine model.

PURPOSE: To develop and evaluate susceptibility corrected 2D proton resonance frequency (PRF)-based magnetic resonance (MR)-thermometry for the accurate assessment of the ablation zone of hepatic microwave ablation (MWA). METHODS AND MATERIALS: Twelve hepatic MWA were performed in five LEWE minipigs with human-like fissure-free liver. Temperature maps during ablation of PRF-based MR-thermometry were corrected by modeling heat induced susceptibility changes. Ablation zones were determined using cumulative equivalent minutes at 43 °C (CEM43) as tissue damage model. T1 weighted (w) post-ablation contrast-enhanced (CE) MR-imaging and manually segmented postmortem histology were used for validation. The agreement of uncorrected (raw) and susceptibility corrected (corr) MR-thermometry with T1w post-ablation CE MR-imaging and histology was evaluated. The Wilcoxon-signed rank test and Bland-Altman analysis were applied. RESULTS: With the susceptibility corrected MR-thermometry a significantly increased dice coefficient (raw: 77% vs. corr: 83%, p < 0.01) and sensitivity (raw: 72% vs. corr: 82%, p < 0.01) was found for the comparison to T1w-CE imaging as well as histopathology (dice coefficients: raw: 76% vs. corr: 79%, p < 0.001; sensitivity: raw: 72% vs. corr: 74%, p < 0.001). While major axis length was significantly increased (7.1 mm, p < 0.001) and minor axis length significantly decreased (2.2 mm, p < 0.001) in uncorrected MR-thermometry compared to T1w-CE MR-imaging, no significant bias was found after susceptibility correction. CONCLUSION: Using susceptibility corrected 2D PRF-based MR-thermometry to predict the ablation zones of hepatic MWA provided a good agreement in comparison to T1w post-ablation CE MR-imaging and histopathology.

Identification of Relevant Attributes for Liver Cancer Therapies (IRALCT): a maximum-difference-scaling analysis.

The Identification of Relevant Attributes for Liver Cancer Therapies (IRALCT) project is intended to provide new insights into the relevant utility attributes regarding therapy choices for malignant primary and secondary liver tumors from the perspective of those who are involved in the decision-making process. It addresses the potential value of taking patients' expectations and preferences into account during the decision-making and, when possible, adapting therapies according to these preferences. Specifically, it is intended to identify the relevant clinical attributes that influence the patients', medical laymen's, and medical professionals' decisions and compare the three groups' preferences. We conducted maximum difference (MaxDiff) scaling among 261 participants (75 physicians, 97 patients with hepatic malignancies, and 89 medical laymen) to rank the importance of 14 attributes previously identified through a literature review. We evaluated the MaxDiff data using count analysis and hierarchical Bayes estimation (HB). Physicians, patients, and medical laymen assessed the same 7 attributes as the most important: probability (certainty) of a complete removal of the tumor, probability of reoccurrence of the disease, pathological evidence of tumor removal, possible complications during the medical intervention, welfare after the medical intervention, duration and intensity of the pain, and degree of difficulty of the medical intervention. The cumulative relative importance of these 7 attributes was 88.3%. Our results show that the physicians', patients', and medical laymen's preferences were very similar and stable.Trial registration DRKS-ID of the study: DRKS00013304, Date of Registration in DRKS: 2017/11/16.

Comparison study of reconstruction algorithms for volumetric necrosis maps from 2D multi-slice GRE thermometry images.

Cancer is a disease which requires a significant amount of careful medical attention. For minimally-invasive thermal ablation procedures, the monitoring of heat distribution is one of the biggest challenges. In this work, three approaches for volumetric heat map reconstruction (Delauney triangulation, minimum volume enclosing ellipsoids (MVEE) and splines) are presented based on uniformly distributed 2D MRI phase images rotated around the applicator's main axis. We compare them with our previous temperature interpolation method with respect to accuracy, robustness and adaptability. All approaches are evaluated during MWA treatment on the same data sets consisting of 13 ex vivo bio protein phantoms, including six phantoms with simulated heat sink effects. Regarding accuracy, the DSC similarity results show a strong trend towards the MVEE ([Formula: see text]) and the splines ([Formula: see text]) method compared to the Delauney triangulation ([Formula: see text]) or the temperature interpolation ([Formula: see text]). Robustness is increased for all three approaches and the adaptability shows a significant trend towards the initial interpolation method and the splines. To overcome local inhomogeneities in the acquired data, the use of adaptive simulations should be considered in the future. In addition, the transfer to in vivo animal experiments should be considered to test for clinical applicability.

Detection of Ablation Boundaries Using Different MR Sequences in a Swine Liver Model.

PURPOSE: To determine the magnetic resonance (MR) sequences best suited for the assessment of ablation zones after radiofrequency ablation (RFA). METHODS: Three percutaneous MR-guided RFA of the liver were performed on three swine. Four pre-contrast and two hepatobiliary post-contrast sequences were obtained after ablation. Tissue samples were extracted and stained for nicotinamide adenine dinucleotide diaphorase hydride (NADH) and with hematoxylin and eosin. Post-ablation MR images and NADH slides were segmented to determine the total ablation zone, their Dice similarity coefficient (DSC), and the contrast-to-noise ratio (CNR) of the visible ablation boundary to normal liver tissue. RESULTS: Two distinct layers were combined to determine the ablation zone: an inner layer of coagulation necrosis and an outer layer defined as the peripheral transition zone. Corresponding zones could be found in the MR images as well. Compared to histology, the total area of the MR ablation zone was significantly smaller on the pre-contrast T1 images (p < 0.01) and significantly larger with T2 turbo spin-echo (p = 0.025). No significant difference in size of the ablation zone depiction could be found between histology, post-contrast T1 volumetric interpolated breath-hold examination (VIBE), and post-contrast T1 3D Turboflash (TFL) as well as T2 SPACE images. All sequences but the pre-contrast T1 VIBE sequence showed a DSC above 80% and a high CNR. CONCLUSIONS: Post-contrast T1 3DTFL performs best when assessing ablation zones after RFA. Since the sequence requires a long acquisition time, T1 VIBE post-contrast offers the best compromise between acquisition time and estimation accuracy.

First experiences and results after cryoablation of prostate cancer with histopathological evaluation and imaging-based follow-up.

Aim: To share our experience after 28 cryoablation treatments for prostate cancer (PCa) with histopathology, clinical data and MRI as the follow-up methods. Methods: Clinical follow-up comprised prostate-specific antigen (PSA)-measurements, PSA-density and quality of life-parameters. multi-parametric (mp)MRI pre- and post-cryoablation were retrospectively re-analyzed in 23 cases using Likert scores. Follow-up-histopathology was performed via MRI/ultrasound fusion-guided and/or systematic biopsy. Receiver operating characteristic curve analysis was performed. Results: 17 PCa (61%) were diagnosed within 12-month post-cryotherapy (infield and out-of-field disease). PSA levels and PSA density were not significantly different between patients with or without PCa recurrence. mpMRI can characterize the decrease in prostate volume and necrosis. Area under the curve for the detection of PCa was 81% (global Likert scores), 74-87% (T2), 78% (diffusion weighted imaging) and 57-78% (dynamic contrast enhanced imaging; Youden-selected cutoff ≥3). Conclusion: Besides histopathological evaluation and control biopsy, MRI might have the potential to accurately detect PCa after cryotherapy. Clinical data and interdisciplinary communication are required for efficient monitoring after cryoablation treatments for PCa.

3D-Printed Floating Cable Traps for MRI guided Microwave Ablation.

Magnetic Resonance Imaging (MRI) guided Microwave Ablation (MWA) allows for real-time therapy monitoring with MRI-thermometry. The MWA generator emits Radio Frequency (RF) interference, which can limit the accuracy of therapy monitoring. The image quality is enhanced by Floating Cable Traps (FCTs) that are used to attenuate common mode currents on supply lines between a MWA generator, and its ablation applicator. The effect of an FCT on the Signal to Noise Ratio (SNR), and changes in the MRI spectrum are discussed in this paper. The application of FCT can bring significant improvements in both, the MRI spectrum and the SNR.Floating Cable Traps are user-friendly. FCT enable coaxial cables to reduce interferences emitted in MRI guided interventions. It is used to selectively attenuate frequencies in the MRI's range. This can increase the image's Signal to Noise Ratio.

Design of a System for Magnetic-Resonance-Guided Irreversible Electroporation.

Irreversible electroporation (IRE) is a non-thermal tumor ablation method where strong electrical fields between at least two electrodes are used and can be seen as an alternative to thermal ablation techniques. The therapy outcome directly dependents on the position of the electrodes. Real-time monitoring of the IRE by magnetic resonance imaging (MRI) would allow to detect unwanted electrode displacement and to apply visualization methods for the ablation area. This requires that the IRE generator does not significantly interfere with the MRI. Currently, there is no IRE generator available designed for MRI-guided IRE.This paper presents an IRE system specifically developed for use in an MRI environment. The system is initially tested with a standard IRE sequence and then the interference between a clinical 3 T MRI device and the IRE system is investigated using a noise measurement and the signal-to-noise ratio (SNR) of images acquired with a gradient echo (GRE) sequence. The results show, that although the SNR of the images decrease by maximal 36 % when the IRE system is switched on, image quality does not visibly degrade. Hence, MRI-guided IRE is feasible with the proposed system.Clinical relevance- This paper demonstrates the possibility of MRI-guided IRE with only minor image degradation when the IRE system is used in parallel with MRI imaging.

Diffusion Weighted Imaging and T2 Mapping Detect Inflammatory Response in the Renal Tissue during Ischemia Induced Acute Kidney Injury in Different Mouse Strains and Predict Renal Outcome.

To characterize ischemia reperfusion injury (IRI)-induced acute kidney injury (AKI) in C57BL/6 (B6) and CD1-mice by longitudinal functional MRI-measurement of edema formation (T2-mapping) and inflammation (diffusion weighted imaging (DWI)). IRI was induced with unilateral right renal pedicle clamping for 35min. 7T-MRI was performed 1 and 14 days after surgery. DWI (7 b-values) and multiecho TSE sequences (7 TE) were acquired. Parameters were quantified in relation to the contralateral kidney on day 1 (d1). Renal MCP-1 and IL-6-levels were measured by qPCR and serum-CXCL13 by ELISA. Immunohistochemistry for fibronectin and collagen-4 was performed. T2-increase on d1 was higher in the renal cortex (127 ± 5% vs. 94 ± 6%, p < 0.01) and the outer stripe of the outer medulla (141 ± 9% vs. 111 ± 9%, p < 0.05) in CD1, indicating tissue edema. Medullary diffusivity was more restricted in CD1 than B6 (d1: 73 ± 3% vs. 90 ± 2%, p < 0.01 and d14: 77 ± 5% vs. 98 ± 3%, p < 0.01). Renal MCP-1 and IL-6-expression as well as systemic CXCL13-release were pronounced in CD1 on d1 after IRI. Renal fibrosis was detected in CD1 on d14. T2-increase and ADC-reduction on d1 correlated with kidney volume loss on d14 (r = 0.7, p < 0.05; r = 0.6, p < 0.05) and could serve as predictive markers. T2-mapping and DWI evidenced higher susceptibility to ischemic AKI in CD1 compared to B6.

Impact of sarcopenia in advanced and metastatic soft tissue sarcoma.

INTRODUCTION: Advanced or metastatic soft tissue sarcoma (a/mSTS) is associated with a dismal prognosis. Patient counseling on treatment aggressiveness is pivotal to avoid over- or undertreatment. Recently, evaluation of body composition markers like the skeletal muscle index (SMI) became focus of interest in a variety of cancers. This study focuses on the prognostic impact of SMI in a/mSTS, retrospectively. METHODS: 181 a/mSTS patients were identified, 89 were eligible due to prespecified criteria for SMI assessment. Baseline CT-Scans were analyzed using an institutional software solution. Sarcopenia defining cut-off values for the SMI were established by optimal fitting method. Primary end point was overall survival (OS) and secondary endpoints were progression free survival (PFS), disease control rate (DCR), overall response rate (ORR). Descriptive statistics as well as Kaplan Meier- and Cox regression analyses were administered. RESULTS: 28/89 a/mSTS patients showed sarcopenia. Sarcopenic patients were significantly older, generally tended to receive less multimodal therapies (62 vs. 57 years, P = 0.025; respectively median 2.5 vs. 4, P = 0.132) and showed a significantly lower median OS (4 months [95%CI 1.9-6.0] vs. 16 months [95%CI 8.8-23.2], Log-rank P = 0.002). Sarcopenia was identified as independent prognostic parameter of impaired OS (HR 2.40 [95%-CI 1.4-4.0], P < 0.001). Moreover, DCR of first palliative medical treatment was superior in non-sarcopenic patients (49.2% vs. 25%, P = 0.032). CONCLUSION: This study identifies sarcopenia as a prognostic parameter in a/mSTS. Further on, the data suggest that sarcopenia shows a trend of being associated with first line therapy response. SMI is a promising prognostic parameter, which needs further validation.

Early antihypertensive treatment and ischemia-induced acute kidney injury.

Acute kidney injury (AKI) frequently complicates major surgery and can be associated with hypertension and progress to chronic kidney disease, but reports on blood pressure normalization in AKI are conflicting. In the present study, we investigated the effects of an angiotensin-converting enzyme inhibitor, enalapril, and a soluble epoxide hydrolase inhibitor, 1-trifluoromethoxyphenyl-3-(1-propionylpiperidin-4-yl)urea (TPPU), on renal inflammation, fibrosis, and glomerulosclerosis in a mouse model of ischemia-reperfusion injury (IRI)-induced AKI. Male CD1 mice underwent unilateral IRI for 35 min. Blood pressure was measured by tail cuff, and mesangial matrix expansion was quantified on methenamine silver-stained sections. Renal perfusion was assessed by functional MRI in vehicle- and TPPU-treated mice. Immunohistochemistry was performed to study the severity of AKI and inflammation. Leukocyte subsets were analyzed by flow cytometry, and proinflammatory cytokines were analyzed by quantitative PCR. Plasma and tissue levels of TPPU and lipid mediators were analyzed by liquid chromatography mass spectrometry. IRI resulted in a blood pressure increase of 20 mmHg in the vehicle-treated group. TPPU and enalapril normalized blood pressure and reduced mesangial matrix expansion. However, inflammation and progressive renal fibrosis were severe in all groups. TPPU further reduced renal perfusion on days 1 and 14. In conclusion, early antihypertensive treatment worsened renal outcome after AKI by further reducing renal perfusion despite reduced glomerulosclerosis.

Integration and evaluation of a gradient-based needle navigation system for percutaneous MR-guided interventions.

The purpose of the present study was to integrate an interactive gradient-based needle navigation system and to evaluate the feasibility and accuracy of the system for real-time MR guided needle puncture in a multi-ring phantom and in vivo in a porcine model. The gradient-based navigation system was implemented in a 1.5T MRI. An interactive multi-slice real-time sequence was modified to provide the excitation gradients used by two sets of three orthogonal pick-up coils integrated into a needle holder. Position and orientation of the needle holder were determined and the trajectory was superimposed on pre-acquired MR images. A gel phantom with embedded ring targets was used to evaluate accuracy using 3D distance from needle tip to target. Six punctures were performed in animals to evaluate feasibility, time, overall error (target to needle tip) and system error (needle tip to the guidance needle trajectory) in vivo. In the phantom experiments, the overall error was 6.2±2.9 mm (mean±SD) and 4.4±1.3 mm, respectively. In the porcine model, the setup time ranged from 176 to 204 seconds, the average needle insertion time was 96.3±40.5 seconds (min: 42 seconds; max: 154 seconds). The overall error and the system error was 8.8±7.8 mm (min: 0.8 mm; max: 20.0 mm) and 3.3±1.4 mm (min: 1.8 mm; max: 5.2 mm), respectively.

Checkpoint Inhibition for Metastatic Urothelial Carcinoma After Chemotherapy-Real-World Clinical Impressions and Comparative Review of the Literature.

Background: The introduction of checkpoint inhibitors is a long-awaited new option for a urothelial cancer with a poor prognosis. Apart from clinical studies, the data on real world experience is scarce. Methods: Patients for monotherapy with either Atezolizumab, Nivolumab or Pembrolizumab after chemotherapy were included. Adverse events and immune related adverse events as well as survival data and imaging analyses were recorded in a prospectively designed multi-center data base. Duration of response, progression free survival (PFS), and overall survival (OS) were estimated with the Kaplan-Meier method. Results: A total of 28 patients were included. The median follow-up was 8.0 (range, 0.7-41.7) months. Median PFS was 5.8 (95% CI, 2.3-NA) months. Median OS for all patients was 10.0 (95% CI, 8.0-NA) months. The overall response rate (ORR) was 21.4% (6 out of 28 patients). Adverse events were recorded in 20 (71.4%) of patients. Higher grade adverse events (≥Grade 3) were present in 11 (39.3%) patients. No therapy related deaths occurred during the observation period. A total of 13 (46.4%) patients had adverse events that were considered to be immune related. The most commonly affected organ was the thyroid gland with 21.4% of events. Conclusion: Our real-world clinical series confirms an objective response for about every fifth patient, promising OS and a low incidence for severe adverse events (≥Grade 3).

Tuberculosis screening during the 2015 European refugee crisis.

BACKGROUND: The purpose of our study was to describe and evaluate management, performance and results of Tuberculosis (TB)-screening among refugees and asylum seekers in a rural area in Germany in 2015. METHODS: Refugees or asylum seekers, staying in shared-accommodation are obligated to participate on screening chest X-ray (CXR) in order to screen for signs of potentially infectious pulmonary TB (German Protection against Infection Act and German Asylum Procedure Act). n = 705 individuals underwent screening chest X-ray (CXR) to detect pulmonary TB in September and October 2015 on site. One experienced radiologist interpreted and reported each CXR within 24 h after the enrollment in the screening program and results were sent to the local Public Health Department for potential further medical care. Image abnormalities suggestive for TB were defined according to established radiographic criteria such as pleural effusion, cavitation, consolidation, fibrous scarring or calcification. Only in case of TB-suggestive findings on CXR, further diagnostics were arranged (pulmonological examination, follow-up CXR, sputum culture, interferon-gamma release assay, bronchoscopy). Follow-up data was collected in collaboration with the local Public Health Department. Descriptive statistics were calculated using GraphPad Prism software. RESULTS: n = 637 CXR examinations (90%) did not show abnormal findings, n = 54 CXR (8%) showed incidental findings, and n = 14 CXR (2%) were suspicious for acute TB. Of these, n = 14 individuals, eight underwent further TB diagnostics. Active TB was confirmed in one individual (0.001% of the screening cohort). CONCLUSIONS: Our cohort reflects current immigrations statistics in Europe and illustrates an overall low TB prevalence amongst individuals entering Germany in 2015. However, our findings support the improvement of diagnostic algorithms.

Touchless scanner control to support MRI-guided interventions.

PURPOSE: MRI-guided interventions allow minimally invasive, radiation-free treatment but rely on real-time image data and free slice positioning. Interventional interaction with the data and the MRI scanner is cumbersome due to the diagnostic focus of current systems, confined space and sterile conditions. METHODS: We present a touchless, hand-gesture-based interaction concept to control functions of the MRI scanner typically used during MRI-guided interventions. The system consists of a hand gesture sensor customised for MRI compatibility and a specialised UI that was developed based on clinical needs. A user study with 10 radiologists was performed to compare the gesture interaction concept and its components to task delegation-the prevalent method in clinical practice. RESULTS: Both methods performed comparably in terms of task duration and subjective workload. Subjective performance with gesture input was perceived as worse compared to task delegation, but was rated acceptable in terms of usability while task delegation was not. CONCLUSION: This work contributes by (1) providing access to relevant functions on an MRI scanner during percutaneous interventions in a (2) suitable way for sterile human-computer interaction. The introduced concept removes indirect interaction with the scanner via an assistant, which leads to comparable subjective workload and task completion times while showing higher perceived usability.

Projector-based augmented reality system for interventional visualization inside MRI scanners.

BACKGROUND: Navigation support in interventional magnetic resonance imaging (MRI) is separated from the operating field, which makes it difficult to interpret positions and orientations and to coordinate the necessary hand movements. METHODS: We developed a projector-based augmented reality system to enable visual navigation of tracked instruments on pre-planned paths and visualization of risk structures directly on the patient inside the MRI bore. To assess the accuracy of the system, a user study was carried out with clinicians in a needle navigation test scenario. RESULTS: The targets were reached with an error of 1.7 ± 0.5 mm and the entry points with an error of 1.7 ± 0.8 mm. CONCLUSION: The accuracy results are similar to those reached by live image-guided interventions and related work and confirm that this projective augmented reality prototype for the interventional MRI can serve as a platform for current and future research in augmented reality visualization and dynamic registration.