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Background: Dementia-related impairments can cause complex barriers to access, use, and adopt digital health technologies (DHTs). These barriers can contribute to digital health inequities. Therefore, literature-based design principles called DEMIGNED have been developed to support the design and evaluation of DHTs for this rapidly increasing population., Objective: This study aims to apply the DEMIGNED principles in usability evaluation methods to (1) capture usability problems on a mobile website providing information resources for people visiting a memory clinic, including those living with subjective cognitive decline (SCD), mild cognitive impairment (MCI), or dementia, and (2) investigate the realness of usability problems captured by the DEMIGNED principles in expert testing, specifically for mobile websites that act as a means of providing DHTs., Methods: First, a heuristic evaluation was conducted, with the DEMIGNED principles serving as domain-specific guidelines, with 3 double experts (experienced in both usability and dementia) and 2 usability engineering experts. Second, think-aloud sessions were conducted with patients visiting a memory clinic who were living with SCD, MCI, or dementia., Results: The heuristic evaluation resulted in 36 unique usability problems. A representative sample of 7 people visiting a memory clinic participated in a think-aloud session, including 4 (57%) with SCD, 1 (14%) with MCI, and 2 (29%) with dementia. The analysis of the think-aloud sessions revealed 181 encounters with usability problems. Of these encounters, 144 (79.6%) could be mapped to 18 usability problems identified in the heuristic evaluation. The remaining 37 (20.4%) encounters from the user testing revealed another 10 unique usability problems. Usability problems frequently described in the think-aloud sessions encompassed difficulties with using the search function, discrepancies between the user's expectations and the content organization, the need for scrolling, information overload, and unclear system feedback., Conclusions: By applying the DEMIGNED principles in expert testing, evaluators were able to capture 79.6% (144/181) of all usability problem encounters in the user testing of a mobile website for people visiting a memory clinic, including people living with dementia. Regarding unique usability problems, 50% (18/36) of the unique usability problems identified during the heuristic evaluation were captured by the user-testing sessions. Future research should look into the applicability of the DEMIGNED principles to other digital health functionalities to increase the accessibility of digital health and decrease digital health inequity for this complex and rapidly increasing population., (©Thomas Engelsma, Simone Heijmink, Heleen M A Hendriksen, Leonie N C Visser, Afina W Lemstra, Monique W M Jaspers, Linda W P Peute. Originally published in JMIR Human Factors (https://humanfactors.jmir.org), 31.07.2024.)

Background and Purpose: Magnetic resonance (MR) guided radiotherapy utilizes MR images for (online) plan adaptation and image guidance. The aim of this study was to investigate the impact of variation in MR acquisition time and scan resolution on image quality, interobserver variation in contouring and interobserver variation in registration., Materials and Methods: Nine patients with prostate cancer were included. Four T2-weighted 3D turbo spin echo (T2w 3D TSE) sequences were acquired with different acquisition times and resolutions. Two radiologists assessed image quality, conspicuity of the capsule, peripheral zone and central gland architecture and motion artefacts on a 5 point scale. Images were delineated by two radiation oncologists and interobserver variation was assessed by the 95% Hausdorff distance. Seven observers registered the MR images on the planning CT. Registrations were compared on systematic offset and interobserver variation., Results: Acquisition times ranged between 1.3 and 6.3 min. Overall image quality and capsule definition were significantly worse for the MR sequence with an acquisition time of 1.3 min compared to the other sequences. Median 95% Hausdorff distance showed no significant differences in interobserver variation of contouring. Systematic offset and interobserver variation in registration were small (<1 mm) and of no clinical significance., Conclusions: Our results can be used to effectively shorten overall fraction time for online adaptive MR guided radiotherapy by optimising the imaging sequence used for registration. From the sequences studied, a sequence of 3.1 min with anisotropic voxels of 1.2 × 1.2 × 2.4 mm 3 provided the shortest acquisition time without compromising image quality., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: NKI-AvL is part of the Elekta MR-linac Consortium and we acknowledge financial and technical support from Elekta AB (Stockholm, Sweden) under a research agreement., (© 2021 Published by Elsevier B.V. on behalf of European Society of Radiotherapy & Oncology.)

Purpose: To assess the intermodality and intertracer variability of gallium-68 ( 68 Ga)- or fluorine-18 ( 18 F)-labeled prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and biparametric magnetic resonance imaging (bpMRI)-based gross tumor volume (GTV) delineation for focal boosting in primary prostate cancer., Methods: Nineteen prospectively enrolled patients with prostate cancer underwent a PSMA PET/MRI scan, divided into a 1:1 ratio between 68 Ga-PSMA-11 and 18 F-PSMA-1007, before radical prostatectomy (IWT140193). Four delineation teams performed manual contouring of the GTV based on bpMRI and PSMA PET imaging, separately. Index lesion coverage (overlap%) and interobserver variability were assessed. Furthermore, the distribution of the voxelwise normalized standardized uptake values (SUV%) was determined for the majority-voted (>50%) GTV (GTV majority ) and whole prostate gland to investigate intertracer variability. The median patientwise SUV% contrast ratio (SUV%-CR, calculated as median GTV majority SUV% / median prostate gland without GTV majority SUV%) was calculated according to the tracer used., Results: A significant difference in overlap% favoring PSMA PET compared with bpMRI was found in the 18 F subgroup (median, 63.0% vs 53.1%; P = .004) but was not present in the 68 Ga subgroup (32.5% vs 50.6%; P = .100). Regarding interobserver variability, measured Sørensen-Dice coefficients (0.58 vs 0.72) and calculated mean distances to agreement (2.44 mm vs 1.22 mm) were statistically significantly lower and higher, respectively, for the 18 F cohort compared with the 68 Ga cohort. For the bpMRI-based delineations, the median Sørensen-Dice coefficient and mean distance to agreement were 0.63 and 1.76 mm, respectively. Median patientwise SUV%-CRs of 1.8 (interquartile range [IQR], 1.6-2.7) for 18 F-PSMA and 3.3 (IQR, 2.7-5.9) for 68 Ga-PSMA PET images were found., Conclusions: Both MRI and PSMA PET provided consistent intraprostatic GTV lesion detection. However, the PSMA tracer seems to have a major influence on the contour characteristics, owing to an apparent difference in SUV% distribution in the prostate gland., (Copyright © 2020 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Background: Oligometastatic prostate cancer (OMPC) is a heterogeneous disease state that is imperfectly understood, and its clinical implications are unclear., Objective: To determine the consensus of a Dutch multidisciplinary expert panel on biological aspects, treatment goals, and management of OMPC in daily clinical practice., Design, Setting, and Participants: The study comprised a modified Delphi method including an explorative survey with various statements and questions, followed by a consensus meeting to discuss and determine the agreement with revised statements and related items. The panel consisted of 34 Dutch representatives from urology, medical and radiation oncology, radiology, nuclear medicine, and basic research., Outcome Measurements and Statistical Analysis: Agreement was determined with statements (five-point scale). Consensus was defined as ≥75% panel agreement with a statement., Results and Limitations: Consensus existed for 56% of statements. The panel agreed that OMPC comprises a limited metastatic spread in the hormone-sensitive setting, in both the synchronous and the metachronous presentation. Limited metastatic spread was believed to involve three to five metastases and a maximum of two organs. Prostate-specific membrane antigen positron emission tomography/computed tomography scan was currently perceived as the most accurate diagnostic imaging modality. Although there was a consensus that targeted treatment of all metastases in OMPC will delay further dissemination of the disease, opinions on specific treatment regimens were divided. Panel outcomes were limited by the lack of scientific evidence on OMPC., Conclusions: A multidisciplinary panel reached a consensus that OMPC is a specific disease state requiring a tailored treatment approach. OMPC registries and clinical studies should focus on both the biology and the clinical parameters in relation to optimal treatment strategies in synchronous and metachronous OMPC., Patient Summary: A group of Dutch medical specialists agreed that prostate cancer patients having few metastases may benefit from a new therapeutic approach. Clinical studies need to determine which treatment is best for each specific situation., (Copyright © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Local recurrent prostate cancer after radical treatment is found in the majority of men with a rising PSA. Salvage treatment procedures for recurrent disease, such as radiation therapy and ablative procedures, can provide long-term responses in well-selected cases. Prostate magnetic resonance imaging (MRI) allows diagnosis and staging, and the value provides information on treatment selection, treatment planning and treatment guidance in local recurrent prostate cancer.

Background: The outcome of patients with macroscopic stage III melanoma is poor. Neoadjuvant treatment with ipilimumab plus nivolumab at the standard dosing schedule induced pathological responses in a high proportion of patients in two small independent early-phase trials, and no patients with a pathological response have relapsed after a median follow up of 32 months. However, toxicity of the standard ipilimumab plus nivolumab dosing schedule was high, preventing its broader clinical use. The aim of the OpACIN-neo trial was to identify a dosing schedule of ipilimumab plus nivolumab that is less toxic but equally effective., Methods: OpACIN-neo is a multicentre, open-label, phase 2, randomised, controlled trial. Eligible patients were aged at least 18 years, had a WHO performance status of 0-1, had resectable stage III melanoma involving lymph nodes only, and measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1. Patients were enrolled from three medical centres in Australia, Sweden, and the Netherlands, and were randomly assigned (1:1:1), stratified by site, to one of three neoadjuvant dosing schedules: group A, two cycles of ipilimumab 3 mg/kg plus nivolumab 1 mg/kg once every 3 weeks intravenously; group B, two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg once every 3 weeks intravenously; or group C, two cycles of ipilimumab 3 mg/kg once every 3 weeks directly followed by two cycles of nivolumab 3 mg/kg once every 2 weeks intravenously. The investigators, site staff, and patients were aware of the treatment assignment during the study participation. Pathologists were masked to treatment allocation and all other data. The primary endpoints were the proportion of patients with grade 3-4 immune-related toxicity within the first 12 weeks and the proportion of patients achieving a radiological objective response and pathological response at 6 weeks. Analyses were done in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02977052, and is ongoing with an additional extension cohort and to complete survival analysis., Findings: Between Nov 24, 2016 and June 28, 2018, 105 patients were screened for eligibility, of whom 89 (85%) eligible patients were enrolled and randomly assigned to one of the three groups. Three patients were excluded after randomisation because they were found to be ineligible, and 86 received at least one dose of study drug; 30 patients in group A, 30 in group B, and 26 in group C (accrual to this group was closed early upon advice of the Data Safety Monitoring Board on June 4, 2018 because of severe adverse events). Within the first 12 weeks, grade 3-4 immune-related adverse events were observed in 12 (40%) of 30 patients in group A, six (20%) of 30 in group B, and 13 (50%) of 26 in group C. The difference in grade 3-4 toxicity between group B and A was -20% (95% CI -46 to 6; p=0·158) and between group C and group A was 10% (-20 to 40; p=0·591). The most common grade 3-4 adverse events were elevated liver enzymes in group A (six [20%)]) and colitis in group C (five [19%]); in group B, none of the grade 3-4 adverse events were seen in more than one patient. One patient (in group A) died 9·5 months after the start of treatment due to the consequences of late-onset immune-related encephalitis, which was possibly treatment-related. 19 (63% [95% CI 44-80]) of 30 patients in group A, 17 (57% [37-75]) of 30 in group B, and nine (35% [17-56]) of 26 in group C achieved a radiological objective response, while pathological responses occurred in 24 (80% [61-92]) patients in group A, 23 (77% [58-90]) in group B, and 17 (65% [44-83]) in group C., Interpretation: OpACIN-neo identified a tolerable neoadjuvant dosing schedule (group B: two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg) that induces a pathological response in a high proportion of patients and might be suitable for broader clinical use. When more mature data confirm these early observations, this schedule should be tested in randomised phase 3 studies versus adjuvant therapies, which are the current standard-of-care systemic therapy for patients with stage III melanoma., Funding: Bristol-Myers Squibb., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objective: To determine the value of gallium-68-prostate-specific membrane antigen ( 68 Ga-PSMA)-11 positron emission tomography (PET) /computed tomography (CT) in men with newly diagnosed prostate cancer., Patients and Methods: We analysed results of 140 men with intermediate- and high-risk prostate cancer. All men underwent 68 Ga-PSMA-11 PET/CT and multiparametric magnetic resonance imaging (mpMRI) before radical prostatectomy (RP) with extended pelvic lymph node (LN) dissection. For each patient, the clinical and pathological features were recorded. Prostate-specific antigen (PSA) was documented at staging scan, and after RP, at a median (interquartile range) of 110 (49-132) days. A PSA level of ≥0.03 ng/mL was classified as biochemical persistence (BCP). Logistic regression was performed for association of clinical variables and BCP., Results: In these 140 patients with intermediate- and high-risk prostate cancer, 27.1% had PSMA PET/CT-positive findings in the pelvic LNs. Sensitivity and specificity for detection of LN metastases were 53% and 88% (PSMA PET/CT) and 14% and 99% (mpMRI), respectively. The overall BCP rate was 25.7%. The BCP rate was 16.7% in men who were PSMA PET/CT LN-negative compared to 50% in men who were PSMA PET/CT LN-positive (P < 0.05). The presence of PSMA-positive pelvic LNs was more predictive of BCP after RP than cT-stage, PSA level, and the Gleason score, adjusted for surgical margins status., Conclusions: 68 Ga-PSMA-11 PET/CT is highly predictive of BCP after RP, and should play an important role informing men with intermediate- or high-risk prostate cancer., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Purpose of Review: This review discusses new findings in penile cancer imaging in relation to the European Association of Urology and National Comprehensive Cancer Network guidelines., Recent Findings: For imaging in penile cancer patients who are candidates for organ-sparing primary treatment, ultrasound with Doppler seems to be the method of choice in addition to physical examination. The sentinel node biopsy (SNB) procedure is used to detect small nodal metastases in clinically node-negative patients. In recent years, this procedure has been enhanced by 3D imaging using single photon emission computed tomography (SPECT) with computed tomography (CT) to improve preoperative localization and interpretation of sentinel nodes, as well as hybrid fluorescent and radioactive tracers to increase intraoperative localization of sentinel nodes. 18F-fluorodeoxyglucose PET (FDG-PET) with CT appears to be mainly useful for pelvic and distant staging in clinically node-positive patients. Other modalities with a potential future role in penile cancer are ultrasound with shear wave elastography, FDG-PET with MRI and ultrasmall paramagnetic iron oxide-enhanced MRI., Summary: Imaging modalities in penile cancer have advanced throughout the years, assisting in treatment decision-making and during invasive procedures.

Objective: The purpose of this study is to compare dispersion MRI and Tofts model (TM) for analysis of quantitative dynamic contrast-enhanced (DCE) MRI (DCE-MRI) for localization of prostate cancer and to assess the correlation between quantitative DCE-MRI parameters and tumor grade., Materials and Methods: This retrospective multicenter study included 80 patients with biopsy-proven prostate cancer who underwent DCE-MRI followed by radical prostatectomy. DCE-MRI parameters were extracted from dispersion MRI analysis (the dispersion parameter [k d ], the flux rate [k ep ], and the intravascular mean transit time) and TM analysis (the forward volume transfer constant [K trans ], k ep , and the extravascular extracellular volume fraction [v e ]). ROIs representing benign and malignant tissue were drawn on each DCE-MRI slice according to the histopathologic findings, and the diagnostic performance of the estimated parameters for the diagnosis of prostate cancer was evaluated using fivefold cross-validation and ROC curve analysis. Further analysis was conducted for the two most relevant parameters (i.e., k d [for dispersion MRI] and k ep [for TM]), to investigate the correlation between DCE-MRI parameters and tumor grade., Results: DCE-MRI parameters were significantly different between benign and malignant prostate tissue (p < 0.0001). The dispersion MRI parameter k d outperformed all other DCE-MRI parameters for prostate cancer diagnosis, showing the highest area under the ROC curve value (p < 0.0001). Only a weak linear correlation (Pearson r = 0.18; p < 0.05) was found between the dispersion parameter and the Gleason grade group., Conclusion: Dispersion MRI outperformed TM analysis, improving the diagnostic performance of quantitative DCE-MRI for prostate cancer localization. Of the DCE-MRI parameters, k d (for dispersion MRI) and k ep (for TM) provided only poor characterization of tumor grade.

Background and Purpose: Accurate delineation of the primary tumour is vital to the success of radiotherapy and even more important for successful boost strategies, aiming for improved local control in oesophageal cancer patients. Therefore, the aim was to assess delineation variability of the gross tumour volume (GTV) between CT and combined PET-CT in oesophageal cancer patients in a multi-institutional study., Materials and Methods: Twenty observers from 14 institutes delineated the primary tumour of 6 cases on CT and PET-CT fusion. The delineated volumes, generalized conformity index (CIgen) and standard deviation (SD) in position of the most cranial/caudal slice over the observers were evaluated. For the central delineated region, perpendicular distance between median surface GTV and each individual GTV was evaluated as in-slice SD., Results: After addition of PET, mean GTVs were significantly smaller in 3 cases and larger in 1 case. No difference in CIgen was observed (average 0.67 on CT, 0.69 on PET-CT). On CT cranial-caudal delineation variation ranged between 0.2 and 1.5 cm SD versus 0.2 and 1.3 cm SD on PET-CT. After addition of PET, the cranial and caudal variation was significantly reduced in 1 and 2 cases, respectively. The in-slice SD was on average 0.16 cm in both phases., Conclusion: In some cases considerable GTV delineation variability was observed at the cranial-caudal border. PET significantly influenced the delineated volume in four out of six cases, however its impact on observer variation was limited.