Germ Cell Tumor

Researchers are studying men with metastatic castration-resistant prostate cancer mCRPC to understand how different PETCT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PETCT scans at different times before starting LuPSMA radioligand therapy RLT, and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PETCT Axumin, 18F-DCFPyL PETCT, and 18F-FDG PETCT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PETCT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating a new behavioral intervention called Goal-focused Emotion-Regulation Therapy GET aimed at reducing distress, improving emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult men diagnosed with testicular cancer. This randomized controlled trial compares GET to Individual Supportive Listening ISL to understand their effects on psychological and biological outcomes. The study focuses on young adults aged 18 to 39 who have completed chemotherapy and experience distress related to their cancer. Participants will be randomly assigned to receive either six sessions of GET or ISL over eight weeks. GET helps patients identify meaningful personal goals, refine them, and develop strategies to overcome obstacles while improving emotional regulation and sense of purpose. ISL provides supportive, non-directive therapy focused on listening and encouraging expression of thoughts and feelings. Both interventions are delivered individually via an interactive video platform to improve access. During the study, participants will complete assessments at baseline, immediately after treatment, and at three- and six-month follow-ups. These include questionnaires measuring depression, anxiety, emotion regulation, goal navigation, career confusion, and spiritual well-being. Researchers will also collect biological samples to measure stress hormones and inflammatory markers. The study aims to evaluate the feasibility, acceptability, and effects of these interventions on psychological distress and biological stress indicators in young adult testicular cancer survivors.

Testicular cancer is a rare adult cancer but the most common solid tumor in young men, with about 90% being germ cell tumors classified as seminoma or non-seminoma. Around 20% of seminoma patients have clinical stage II disease with limited retroperitoneal lymph node metastases. This trial explores an alternative to standard radiotherapy or chemotherapy treatments, which carry risks of serious short- and long-term side effects, by evaluating the role of surgery called Primary Retroperitoneal Lymph Node Dissection RPLND.

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

Researchers are conducting a multicenter observational study to understand hereditary ovarian cancer among Chinese patients. The study aims to describe the clinical and genetic features of hereditary ovarian cancer and establish a risk prediction model to estimate cancer risk in first-degree relatives of mutation carriers. It also seeks to identify new tumor-causing mutations in families with hereditary ovarian cancer where known genetic causes are not found. Participants include patients diagnosed with epithelial ovarian cancer, divided into two groups those with suspected gene mutations or a family history of cancer, and those without these factors. The study will follow these groups from 2024 to 2026 to analyze clinical, pathological, and genetic information. Through genetic sequencing and family history, the research team will explore new genetic mechanisms and verify the risk prediction model. Participants will undergo genetic testing and clinical evaluations over the study period from 2024 to 2026. Researchers will collect data on tumor features, gene mutations, and family histories. The primary outcome is to describe clinicopathological and genetic characteristics of hereditary ovarian cancer. Secondary outcomes include monitoring new ovarian cancer cases in first-degree relatives. The study aims to guide personalized diagnosis, treatment, and preventive interventions for high-risk families.

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Diagnosing ovarian cancer definitively requires surgery since current tests cannot reliably distinguish between benign and malignant ovarian abnormalities before surgery. Researchers are evaluating the Cleo Diagnostics CleoDX Ovarian Adnexal Mass Score Test System, which measures five blood biomarkers to better assess the likelihood of cancer in patients with ovarian masses needing surgery. This test aims to help doctors make more informed decisions about surgery and patient care by providing a more accurate pre-surgical cancer risk assessment. The study involves patients with ovarian cysts or adnexal masses identified by imaging who require surgery but have not yet undergone it. The CleoDX test analyzes blood samples to generate a score indicating cancer risk, and patients are categorized after surgery as having malignant or benign masses. The study compares the CleoDX test results to standard clinical assessments and post-surgical pathology to evaluate the tests accuracy and performance. Participants will provide blood samples before surgery, and their clinical and pathological information will be collected and analyzed. The primary outcome is the calculation of the CleoDX adnexal mass score, with secondary outcomes comparing the tests score to clinical and pathological findings. Data analysis will take place after patient recruitment, continuing for up to 12 months or until the study ends in August 2026. The study involves monitoring and evaluating the tests ability to predict cancer risk accurately before surgery.

This research aims to provide continued access to niraparib and to further assess its long-term safety in participants with ovarian or breast neoplasms who are currently receiving niraparib treatment within previous GlaxoSmithKlineTESARO-sponsored studies. It focuses on participants who have completed earlier studies where the primary objectives were met and are judged by their doctors to still benefit from niraparib. The study is a phase 2, open-label extension trial designed to monitor treatment continuation and safety over time. Participants will receive niraparib once daily by mouth, following the same dose and schedule as in their previous parent study. Treatment is organized in 90-day cycles and will continue until disease progression, unacceptable side effects, new anticancer therapy unrelated to the parent study, withdrawal, or other reasons for discontinuation occur. The dosing regimen mirrors what was assigned in the prior study, ensuring consistency for each participant. During the study, participants will have regular evaluations to monitor safety and health status for up to five years. These assessments include tracking adverse events, serious side effects, and specific safety concerns, as well as monitoring physical exams, vital signs, blood tests, and medication use. Participants must comply with scheduled visits and treatments while using effective contraception if of childbearing potential. The study duration and follow-up are designed to gather detailed long-term safety information on niraparib treatment.

Researchers are evaluating a new PET imaging agent called 68Ga-MY6349 to improve diagnosis and monitoring of prostate cancer and other aggressive tumors. This study aims to overcome limitations of current methods like PSA tests and PSMA PETCT, which may miss some tumors or lack detailed tumor information. The new probe targets Trop2, a protein highly expressed in many cancers, to provide a whole-tumor assessment in living patients, supporting earlier diagnosis and better treatment planning. Participants will receive a single injection of the 68Ga-MY6349 tracer followed by PETCT imaging to visualize cancer presence and activity. This novel agent is compared to existing imaging agents like 68Ga-PSMA-11, with hopes of detecting more lesions and providing more sensitive and specific results. The study involves a single administration and imaging session per participant. During the study, participants undergo PETCT scans after receiving the tracer to assess tumor detection and uptake. Researchers will measure diagnostic accuracy over two years, including counting the number of lesions and standardized uptake values SUV to evaluate tracer performance. The trial includes safety monitoring and requires participant consent and adherence to the imaging protocol, lasting up to two years for outcome evaluation.

This research evaluates a new imaging method combining electromagnetic tracking with laparoscope and ultrasound probe imaging to improve surgeries for patients with confirmed urologic cancers. These cancers may affect the bladder, prostate, testicle, kidney, urethra, penis, ureter, or scrotum. The study aims to enhance visualization and localization of affected areas during lymph node dissection or organ removal surgeries, potentially reducing complexity, complications, and improving outcomes. Participants will undergo surgeries using a standard laparoscope and ultrasound probe equipped with an electromagnetic sensor to track lymph nodes or organs of interest. This imaging protocol is expected to record data in under 10 minutes during the procedure. The study is a pilot trial involving 10 participants and is supported by Siemens Medical USA. Participants will be monitored through laparoscope and ultrasound images and electromagnetic tracking data over one year. Researchers will assess the accuracy of navigation retrospectively. The involvement includes scheduled surgeries with laparoscopic lymph node dissection andor organ removal, supported by imaging and tracking to evaluate this novel approach. The study is led by Dana-Farber Cancer Institute and runs until December 2026.

Researchers are evaluating the safety, tolerability, how the body processes and responds to the drug, and the anti-tumor activity of BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human study focuses on participants with locally advanced or metastatic solid tumors including hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors, and glypican-3-positive squamous non-small cell lung cancer. The trial aims to determine safe dosage levels and preliminary effectiveness in these advanced cancer types. Participants receive intravenous infusions of BGB-B2033 either alone or combined with tislelizumab and bevacizumab in several dose escalation and expansion cohorts. The study includes ascending doses of BGB-B2033 monotherapy, combination therapies to find maximum tolerated doses and recommended doses for further testing, and safety expansion groups. Some participants are from Asian countries and others from the United States, focusing on hepatocellular carcinoma in these regions. Throughout the study, participants are closely monitored for adverse events and responses to treatment for up to approximately 2 years. Assessments include safety evaluations, measuring tumor responses by independent review and investigators, pharmacokinetic and pharmacodynamic tests, and antibody development against the study drug. Tumor tissue samples are required for certain parts of the study. This comprehensive follow-up helps researchers understand the study drugs activity and safety in advanced cancers.