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Background Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, including enhancing oversight, improving reliability of central monitoring techniques and helping prepare for database lock and trial analyses. Despite this, there is little evidence to support best practice, and current standard methods may not be optimal. Methods We report novel methods from the Trial of Imaging and Schedule in Seminoma Testis (TRISST), a UK-based, multi-centre, phase III trial using paper Case Report Forms to collect data over a 6-year follow-up period for 669 patients. Using an automated database report which summarises the data return rate overall and per centre, we developed a Microsoft Excel-based tool to allow observation of per-centre trends in data return rate over time. The tool allowed us to distinguish between forms that can and cannot be completed retrospectively, to inform understanding of issues at individual centres. We reviewed these statistics at regular trials unit team meetings. We notified centres whose data return rate appeared to be falling, even if they had not yet crossed the pre-defined acceptability threshold of an 80% data return rate. We developed a set method for agreeing targets for gradual improvement with centres having persistent data return problems. We formalised a detailed escalation policy to manage centres who failed to meet agreed targets. We conducted a post-hoc, descriptive analysis of the effectiveness of the new processes. Results The new processes were used from April 2015 to September 2016. By May 2016, data return rates were higher than they had been at any time previously, and there were no centres with return rates below 80%, which had never been the case before. In total, 10 centres out of 35 were contacted regarding falling data return rates. Six out of these 10 showed improved rates within 6–8 weeks, and the remainder within 4 months. Conclusions Our results constitute preliminary effectiveness evidence for novel methods in monitoring and managing data return rates in randomised controlled trials. We encourage other researchers to work on generating better evidence-based methods in this area, whether through more robust evaluation of our methods or of others.

ObjectivesTo evaluate whether a computed tomography (CT) radiomics–based machine learning classifier can predict histopathology of lymph nodes (LNs) after post-chemotherapy LN dissection (pcRPLND) in patients with metastatic non-seminomatous testicular germ cell tumors (NSTGCTs).MethodsEighty patients with retroperitoneal LN metastases and contrast-enhanced CT were included into this retrospective study. Resected LNs were histopathologically classified into “benign” (necrosis/fibrosis) or “malignant” (viable tumor/teratoma). On CT imaging, 204 corresponding LNs were segmented and 97 radiomic features per LN were extracted after standardized image processing. The dataset was split into training, test, and validation sets. After stepwise feature reduction based on reproducibility, variable importance, and correlation analyses, a gradient-boosted tree was trained and tuned on the selected most important features using the training and test datasets. Model validation was performed on the independent validation dataset.ResultsThe trained machine learning classifier achieved a classification accuracy of 0.81 in the validation dataset with a misclassification of 8 of 36 benign LNs as malignant and 4 of 25 malignant LNs as benign (sensitivity 88%, specificity 72%, negative predictive value 88%). In contrast, a model containing only the LN volume resulted in a classification accuracy of 0.68 with 64% sensitivity and 68% specificity.ConclusionsCT radiomics represents an exciting new tool for improved prediction of the presence of malignant histopathology in retroperitoneal LN metastases from NSTGCTs, aiming at reducing overtreatment in this group of young patients. Thus, the presented approach should be combined with established clinical biomarkers and further validated in larger, prospective clinical trials.Key Points• Patients with metastatic non-seminomatous testicular germ cell tumors undergoing post-chemotherapy retroperitoneal lymph node dissection of residual lesions show overtreatment in up to 50%.• We assessed whether a CT radiomics–based machine learning classifier can predict histopathology of lymph nodes after post-chemotherapy lymph node dissection.• The trained machine learning classifier achieved a classification accuracy of 0.81 in the validation dataset with a sensitivity of 88% and a specificity of 78%, thus allowing for prediction of the presence of viable tumor or teratoma in retroperitoneal lymph node metastases.

Objectives The Scrotal and Penile Imaging Working Group (SPIWG) of the European Society of Urogenital Radiology (ESUR) aimed to formulate recommendations on the imaging modalities and minimal technical requirements for abdominopelvic imaging in the follow-up of adult patients treated for testicular germ-cell tumors (TGCT). Methods The SPIWG members performed an extensive literature search, reviewed the current clinical practice, and reached a consensus based on the opinions of experts in the field. Results Recurrence in patients treated for TGCT mainly occurs in retroperitoneal lymph nodes (LNs). Abdominopelvic CT and MRI are equivalent assessing retroperitoneal LNs. MRI has the advantage of avoiding radiation exposure, and moreover, diffusion-weighted images (DWI) may increase the detection rates without the need for contrast administration. In patients treated for stage I TGCT, the ESUR-SPIWG recommends MRI over CT for the detection of retroperitoneal LNs during the follow-up after treatment. CT, however, remains the follow-up imaging of choice in patients with advanced disease. When MRI is used, the recommended minimal requirements are at least one high-quality anatomical sequence (T1-WI or T2-WI) in axial and coronal planes, and DWI in the same axial plane, ≤ 4 mm contiguous slices from the diaphragm to the perineum. When CT is used, the recommended minimal requirement is a standard-dose contrast-enhanced CT in the portal-venous phase, scanned from the diaphragm to the perineum. Conclusions In this paper, the ESUR-SPIWG provides recommendations on the imaging modalities and minimal technical requirements for abdominopelvic imaging in the follow-up of adult patients treated for TGCT. Key Points Question There are no recommendations on the preferred imaging modality or scan sequences required for abdominopelvic imaging in the follow-up after treatment for testicular cancers. Findings The European Society of Urogenital Radiology Scrotal and Penile Imaging Working Group (ESUR-SPIWG) provides recommendations for abdominopelvic imaging in follow-up after treatment for testicular cancers. Clinical relevance Recurrence of testicular germ-cell tumors mainly occurs in retroperitoneal lymph nodes. Both CT and MRI provide similar morphological assessments, but radiation exposure can be avoided by using MRI instead of CT.

Objectives The subcommittee on scrotal imaging, appointed by the board of the European Society of Urogenital Radiology (ESUR), have produced guidelines on imaging and follow-up in testicular microlithiasis (TML). Methods The authors and a superintendent university librarian independently performed a computer-assisted literature search of medical databases: MEDLINE and EMBASE. A further parallel literature search was made for the genetic conditions Klinefelter’s syndrome and McCune-Albright syndrome. Results Proposed guidelines are: follow-up is not advised in patients with isolated TML in the absence of risk factors (see Key Points below); annual ultrasound (US) is advised for patients with risk factors, up to the age of 55; if TML is found with a testicular mass, urgent referral to a specialist centre is advised. Conclusion Consensus opinion of the scrotal subcommittee of the ESUR is that the presence of TML alone in the absence of other risk factors is not an indication for regular scrotal US, further US screening or biopsy. US is recommended in the follow-up of patients at risk, where risk factors other than microlithiasis are present. Risk factors are discussed and the literature and recommended guidelines are presented in this article. Key Points • Follow up advised only in patients with TML and additional risk factors. • Annual US advised for patients with risk factors up to age 55. • If TML is found with testicular mass, urgent specialist referral advised. • Risk factors – personal/ family history of GCT, maldescent, orchidopexy, testicular atrophy.

Objective To determine whether small, incidentally detected testicular lesions can be safely followed up, by assessing growth rate and volume threshold for benign vs. malignant lesions. Methods This retrospective observational study includes a consecutive series of 130 testicular incidentalomas < 1 cm and with negative tumour markers identified from October 2001 to November 2022, which were initially followed up with ultrasound. A total of 39 cases proceeded to surgery during the study period, either due to lesion growth ( n  = 28) or patient preference/recommendation by the referring urologist ( n  = 11). For the lesions that were growing, specific growth rate (SGR) and doubling time (DT) were calculated assuming an exponential growth pattern. In addition, the velocity of increase of the average diameter (∆D av ) and of the maximum diameter (∆D max ) were calculated. Results Of the 130 nodules that were initially followed up, six disappeared, eight were reduced in size, eighty-eight were stable, and twenty-eight increased in size. For operated nodules all 18 malignant tumours, 8/9 benign tumours, and 2/12 surgically proved non-neoplastic lesions were growing. The best cut-off values of the growth indicators to differentiate between malignant and non-malignant histology were 3.47 × 10 −3 %volume/day, ≤ 179 days, > 10 × 10 −3  mm/day, and > 5 × 10 −3  mm/day for SGR, DT, ∆D max , ∆D av , respectively. Conclusions Malignant and non-malignant small incidentalomas can be effectively differentiated based on growing parameters, even though overlap exists. An increase of the maximum diameter of about 1 mm and 2 mm in three months and in six months, respectively, suggests malignancy. Clinical relevance statement Growing parameters allow an educated assessment of benign and malignant small testicular incidentalomas. Non-aggressive management is justified and safe when follow-up includes self-examination and tumour marker assessment to reduce the risk of interval tumour growth. Key Points Small, non-palpable and asymptomatic testicular nodules <   1   cm are unexpectedly discovered during scrotal ultrasound . Growth indicators estimate the potential malignancy, even though overlap with non-malignant lesions exists . Non-growing incidentalomas can be safely followed up .

Abstract Background Testicular seminomas in horses are infrequently reported in the veterinary literature and long-term survival and metastatic potential are not well documented. Hypothesis/Objectives Describe the clinical, imaging, and histologic features in 9 horses with testicular seminoma. Animals Medical records of 9 horses diagnosed with testicular seminoma at a referral hospital between 2000 and 2024 were reviewed. Methods Horses were included if seminoma was confirmed on histopathology from biopsy or necropsy. Information retrieved included signalment, history, clinical pathology, ultrasonographic findings, treatment, and outcome. Results Median age was 18 years (range, 8-26). Three of 9 horses presented for systemic disease (colic, 2; ventral edema, 1). All 3 had large abdominal masses palpable on rectal examination and were euthanized after diagnostic evaluation. Six horses presented for unilateral testicular enlargement (5) or cryptorchid castration (1). These horses underwent castration and the removed testes had features of malignancy with lymphatic neoplastic emboli. Five of 6 horses were euthanized between 4 months and 3 years after castration because of acute weight loss and abdominal masses identified on rectal examination or ultrasonographic examination, attributable to metastatic spread. One additional horse was euthanized for unrelated reasons. Conclusions and clinical importance Horses presented with testicular enlargement and diagnosis of testicular seminoma should undergo diagnostic screening, including transabdominal or transrectal ultrasonographic examination to determine the presence of possible metastasis. Negative screening results at the time of diagnosis do not rule out the possibility of metastasis, and frequent screening at regular intervals is prudent in such cases. Horses with testicular seminoma of retained or descended testicles have a poor long term prognosis because of high potential for metastatic spread.

While post-chemotherapy retroperitoneal lymph node dissection (PC-RPLND) benefits patients with teratoma or viable germ cell tumors (GCT), it becomes overtreatment if necrosis is detected in PC-RPLND specimens. Serum microRNA-371a-3p correctly predicts residual viable GCT with 100% sensitivity; however, prediction of residual teratoma in PC-RPLND specimens using current modalities remains difficult. Therefore, we developed a machine learning model using CT imaging and clinical variables to predict the presence of residual teratoma in PC-RPLND specimens. This study included 58 patients who underwent PC-RPLND between 2005 and 2019 at the University of Tsukuba Hospital. On CT imaging, 155 lymph nodes were identified as regions of interest (ROIs). The ResNet50 algorithm and/or Support Vector Machine (SVM) classification were applied and a nested, 3-fold cross-validation protocol was used to determine classifier accuracy. PC-RPLND specimen analysis revealed 35 patients with necrosis and 23 patients with residual teratoma, while histology of 155 total ROIs showed necrosis in 84 ROIs and teratoma in 71 ROIs. The ResNet50 algorithm, using CT imaging, achieved a diagnostic accuracy of 80.0%, corresponding to a sensitivity of 67.3%, a specificity of 90.5%, and an AUC of 0.84, whereas SVM classification using clinical variables achieved a diagnostic accuracy of 74.8%, corresponding to a sensitivity of 59.0%, a specificity of 88.1%, and an AUC of 0.84. Our machine learning models reliably distinguish between necrosis and residual teratoma in clinical PC-RPLND specimens.

Background Different types of testicular tumours require different treatments. Malignant germ cell tumours usually require radical orchiectomy, while benign tumours may only require excision of the mass. Currently, conventional imaging examinations are difficult to diagnose testicular pathology types. Since testicular tumours are mainly malignant germ cell tumours, puncture of such tumours may lead to tumour metastasis. Therefore, testicular tumours are generally not recommended for puncture biopsy, and radical orchiectomy is performed directly, which inevitably leads to the mistaken removal of testicles in some patients with benign tumours.Since ultrasound texture analysis can evaluate tumour echoes and uniformity in greater detail and with greater accuracy than grey-scale ultrasound, it is helpful in distinguishing tumour pathology types. Methods This study is a retrospective analysis that included 86 patients (with a total of 89 testicular lesions) with pathologically confirmed primary testicular tumours at our hospital between February 2017 and June 2021. The patients were divided into four groups based on pathological results: epidermoid cyst group, sertoli-leydig cell tumour group, lymphoma group, and malignant germ cell tumour group. A retrospective analysis was conducted on conventional ultrasound and its textural analysis performance, which was then compared with pathological findings. Count data were assessed using a paired chi-square test to evaluate the diagnostic performance of both examination methods.Subsequently, a binary logistic regression analysis was conducted on the nine texture feature parameters alongside age and size to derive predictive probability values, thereby achieving comprehensive combined diagnosis. These parameters and the combined results were then plotted on a ROC curve, with the corresponding area under the curve (AUC) calculated. Results This study included a total of 89 testicular lesions, including 10 cases of sertoli-leydig cell tumours; 18 cases of epidermoid cysts; 19 cases of lymphoma; and 42 cases of malignant germ cell tumours. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of conventional ultrasound diagnosis for sertoli-leydig cell tumours were 40.0%, 96.2%, 57.1%, 92.7%, and 89.9%, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of conventional ultrasound diagnosis of testicular epidermoid cysts were 22.2%, 100.0%, 100.0%, 83.5%, and 84.3%, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of conventional ultrasound diagnosis for lymphoma were 15.8%, 90.0%, 30.0%, 79.7%, and 74.2%, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of conventional ultrasound diagnosis for malignant germ cell tumours were 19.0%, 89.4%, 61.5%, 55.3%, and 56.2%, respectively. Using the one-sample K-S test to examine the normality of texture parameters (min gray, max gray, standard, skewness, contrast, sum average, difference variance, difference entropy, and dissimilarity) in testicular tumours alongside patient age and tumour size, it was found that standard, sum average, and tumour size conformed to normal distribution, whilst the remaining parameters did not. Subsequently, these nine texture feature parameters were combined with age and size in a binary logistic regression analysis to derive predictive probability values for comprehensive joint diagnosis. ROC curves were plotted for the nine texture feature parameters, age, size, and the full joint model. Plot ROC curves for the sertoli-leydig cell tumour group and the unsertoli-leydig cell tumour group. resulting in a maximum AUC of 0.992 for the combined groups. Based on the AUC curve, the combined groups with an AUC > 0.148 demonstrated sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 100.0%, 96.2%, 76.9%, 100.0%, and 96.6%, respectively, for diagnosing sertoli-leydig cell tumours. ROC curves were plotted for the epidermoid cyst group and the non-epidermoid cyst group. yielding a maximum AUC of 0.970 for the combined group. Based on the AUC curve, the combined group with an AUC > 0.357 demonstrated sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 94.4%, 95.8%, 85.0%, 98.6%, and 95.5%, respectively, for diagnosing epidermoid cysts. ROC curves were plotted for the lymphoma group and the non-lymphoma group, yielding a maximum AUC of 0.971 for all combined variables. Based on the AUC curve, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of all combined variables > 0.136 for diagnosing lymphoma were 100.0%, 87.1%, 67.9%, 100.0%, and 89.9%, respectively. ROC curves were plotted for the malignant germ cell tumour group and the non-malignant germ cell tumour group. yielding a maximum AUC of 0.809 for the combined groups. Based on the AUC curve, the combined groups with an AUC > 0.560 demonstrated sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 66.7%, 93.6%, 90.3%, 75.9%, and 80.9%, respectively, for diagnosing malignant germ cell tumours. The combined use of all methods significantly improved the accuracy of conventional ultrasound diagnosis, with statistically significant differences. Conclusion Ultrasound texture analysis combined with age and size can provide a relatively accurate pathological classification diagnosis of epidermoid cysts, lymphoma, sertoli-leydig cell tumours, and malignant germ cell tumours, thereby improving the accuracy of routine ultrasound diagnosis. Different pathological types of testicular tumours require different treatment plans, and preoperative ultrasound diagnosis is of great significance as it can guide clinical treatment and preserve the testicles of some patients.

BackgroundTesticular germ cell tumors (GCTs) are aggressive but highly curable tumors. To avoid over/undertreatment, reliable clinical staging of retroperitoneal lymph-node metastasis is necessary. Current clinical guidelines, in their different versions, lack specific recommendations on how to measure lymph-node metastasis.ObjectiveWe aimed to assess the practice patterns of German institutions frequently treating testicular cancer for measuring retroperitoneal lymph-node size.MethodsAn 8‐item survey was distributed among German university hospitals and members of the German Testicular Cancer Study Group.ResultsIn the group of urologists, 54.7% assessed retroperitoneal lymph nodes depending on their short-axis diameter (SAD) (33.3% in any plane, 21.4% in the axial plane), while 45.3% used long-axis diameter (LAD) for the assessment (42.9% in any plane, 2.4% in the axial plane). Moreover, the oncologists mainly assessed lymph-node size based on the SAD (71.4%). Specifically, 42.9% of oncologists assessed the SAD in any plane, while 28.5% measured this dimension in the axial plane. Only 28.6% of oncologists considered the LAD (14.3% in any plane, 14.3% in the axial plane). None of the oncologists and 11.9% of the urologists (n = 5) always performed an MRI for the initial assessment, while for follow-up imaging, the use increased to 36.5% of oncologists and 31% of urologists. Furthermore, only 17% of the urologists, and no oncologists, calculated lymph-node volume in their assessment (p = 0.224).ConclusionClear and consistent measurement instructions are urgently needed to be present in all guidelines across different specialistic fields involved in testicular cancer management.

PurposeOne of the main issues in testicular germ cell tumors (TGCTs) management is to reduce the necessary amount of treatment to achieve cure. Excess treatment burden may arise from late diagnosis of the primary as well as from false positive or negative staging results. Correct imaging is of paramount importance for successful management of TGCT. The aim of this review is to point out the current state of the art as well as innovative developments in TGCT imaging on the basis of three common challenging clinical situations.MethodsA selective literature search was performed in PubMed, Medline as well as in recent conference proceedings.ResultsRegarding small testicular lesions, recent studies using elastography, contrast-enhanced ultrasound or magnetic resonance imaging (MRI) showed promising data for differentiation between benign and malignant histology. For borderline enlarged lymph nodes FDG-PET-CT performance is unsatisfactory, promising new techniques as lymphotropic nanoparticle-enhanced MRI is the subject of research in this field. Regarding the assessment of postchemotherapeutic residual masses, the use of conventional computerized tomography (CT) together with serum tumor markers is still the standard of care. To avoid overtreatment in this setting, new imaging modalities like diffusion-weighted MRI and radiomics are currently under investigation. For follow-up of clinical stage I TGCTs, the use of MRI is non-inferior to CT while omitting radiation exposure.ConclusionFurther efforts should be made to refine imaging for TGCT patients, which is of high relevance for the guidance of treatment decisions as well as the associated treatment burdens and oncological outcomes.