Ovarian Cancer

Researchers are studying the metabolism of cells in the ascites fluid of ovarian cancer patients to better understand the tumour environment. This observational study involves women aged 18 and older who have ascites caused by diagnosed ovarian cancer. The study aims to trace how glucose is taken up and metabolized by tumour and T cells in the ascites. Participants will receive an intravenous infusion of specially labeled glucose U-13Cglucose during their scheduled paracentesis procedure. The infusion starts with 8 grams of labeled glucose in 60 mL over 10 minutes, followed by 4 grams in 30 mL over one hour, continuing until the ascites fluid is drained or up to 5 hours. A continuous glucose monitor tracks blood glucose levels throughout. Samples of ascites fluid collected during the infusion will be kept on ice and analyzed for metabolic activity and metabolite profiles using flow cytometry and mass spectrometry. During the study, participants will wear a glucose monitor before paracentesis and have ascites fluid collected hourly for up to 5 hours. Researchers will measure glucose enrichment and compare metabolic pathways in different cell types within the ascites. They will also correlate metabolic profiles with T cell function. The study involves close monitoring of blood glucose and sample analysis to understand tumour and immune cell metabolism in ovarian cancer ascites.

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 12a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are evaluating a new PET imaging tracer called 18FFAPI-74 to detect cancer by targeting the fibroblast-activation protein FAP found in cancer-associated fibroblasts. This study aims to compare 18FFAPI-74 PET scans to the standard 18F-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytomaparaganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute NCI. Participants will receive an intravenous dose of 18FFAPI-74 before undergoing PETCT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by 18FFAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline 18FFAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

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 the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are evaluating the use of 3D-printed custom applicators for intracavitary high-dose-rate HDR brachytherapy in patients with gynaecological cancers, including endometrial, vaginal, vulva, and recurrent gynaecological cancers. This Phase IIa non-randomised pilot trial aims to assess the feasibility of treating patients using these patient-specific devices, which could offer a more precise and efficient alternative to traditional cylinder-type applicators or custom wax moulds. The study is sponsored by Royal North Shore Hospital and addresses current challenges in applicator design and construction. Participants will receive treatment using 3D-printed custom applicators designed to match optimal planning specifications for HDR brachytherapy. This innovative approach may reduce the time and labor involved in applicator preparation compared to standard wax moulds, while providing a robust and tailored device for therapy. The study focuses on intracavitary brachytherapy procedures for eligible female patients with certain stages of gynaecological cancer. During the study, patients will be closely monitored for treatment success, radiation therapy toxicities, and quality of treatment plans. Researchers will also evaluate the feasibility of MR-only and CT-only planning procedures, optimize applicator design, and assess resource use and costs. Patient experience and acceptability will be measured via questionnaires over a five-year follow-up. Safety and effectiveness outcomes will be carefully tracked to understand the potential benefits and challenges of this new technology.

Researchers are investigating the use of 3D ultrasound imaging during brachytherapy treatment for gynecological cancers, including primary or recurrent vaginal, endometrial, and cervical cancers. This study aims to improve needle placement accuracy in interstitial or intra-cavitary brachytherapy, which is important for delivering adequate radiation doses to tumors while protecting healthy pelvic organs. Currently, there is no standard real-time image guidance for needle insertion in these procedures, which this research seeks to address. The study involves patients receiving gynecological brachytherapy using a device-based approach, where needles and applicators are inserted under general anesthesia with guidance from clinical exams and pre-procedure MRI. An investigational 3D ultrasound device will be used during the procedure to provide real-time volumetric imaging of needle pathways, improving upon the limitations of standard 2D ultrasound. After the procedure, CT scans are performed for radiation planning. Participants will undergo imaging assessments including MRI before treatment and CT after treatment, with the main focus on measuring the accuracy of needle placement over a 16-month period. The study team will evaluate how effectively the 3D ultrasound helps avoid needle insertion into pelvic organs and optimizes tumor dose coverage. Patient safety and treatment monitoring will be conducted alongside these measurements within the study timeline.

Researchers are evaluating the safety, feasibility, and diagnostic accuracy of a new PET tracer called 68Ga-SorB targeting Sortilin, a receptor highly expressed in several solid tumors including melanoma, liver, lung, pancreatic, breast, and ovarian cancers. This exploratory diagnostic study compares 68Ga-SorB PETCT imaging to the standard 18F-FDG PETCT, aiming to improve tumor detection and characterization by using a more tumor-specific tracer with fewer false positives. Participants will receive a single intravenous dose of 68Ga-SorB followed by whole-body PETCT imaging about 60 minutes after injection. The study compares these imaging results with clinically indicated 18F-FDG PETCT scans done within a set timeframe. No therapeutic treatments are given as part of this study. Approximately 40 to 50 adults with confirmed or suspected tumors will be enrolled for imaging and follow-up. During the study, participants are monitored for adverse events from tracer administration until about 24 hours post-imaging. Tumor uptake is measured using quantitative PET parameters such as SUVmax and tumor-to-background ratio. Follow-up includes pathology review and clinical assessments up to 3 months after imaging to evaluate lesion detection, diagnostic sensitivity, specificity, and overall accuracy. This research will provide initial clinical evidence to support further development of Sortilin-targeted imaging and potential future therapeutic applications.

Researchers are conducting a multi-center, open-label, single-arm Phase 12 study to evaluate the safety, radiation dosimetry, and early diagnostic performance of 18FFPyQCP in detecting several types of cancers including colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study aims to assess how well this imaging agent works in these selected oncology conditions and understand its radiation exposure to patients. Participants receive a single dose of 18FFPyQCP followed by positron emission tomography PETcomputed tomography CT imaging during the PETCT imaging visit. The study includes two cohorts focusing on radiation dosimetry and diagnostic accuracy. Cohort A participants undergo radiation dosimetry assessment up to 360 minutes after injection, while Cohort B participants are evaluated for diagnostic performance in the peritoneum with follow-up procedures lasting up to 42 days. During the study, participants undergo PETCT scans and are monitored for adverse events from screening until 48 hours after injection. Women of childbearing potential must have negative pregnancy tests before imaging and use contraception during the study. Researchers will measure radiation dose, imaging accuracy, and safety outcomes. The total participation time ranges from the screening visit through follow-up assessments, up to approximately 42 days post injection.

Researchers are evaluating the use of 68GaBED003, a diagnostic imaging agent, in detecting multiple types of cancer including colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast carcinoma, and epithelial ovarian cancer. This Phase 2, open-label, single-arm study aims to assess how well 68GaBED003 performs in identifying these cancers through imaging techniques. Each participant will receive an injection of 68GaBED003 followed by positron emission tomography PETcomputed tomography CT scans during the imaging visit. The study includes a screening period, the imaging procedure, and a brief safety follow-up. The main focus is on the diagnostic accuracy of 68GaBED003, including tumor uptake and optimal imaging timing and dosage. Participants will undergo screening to confirm eligibility, including performance status and pregnancy testing for women of childbearing potential. They will receive the imaging agent and have PETCT scans at the imaging visit. Safety and tolerability are monitored up to 48 hours after injection, with follow-up assessments up to 42 days. The study measures how well 68GaBED003 detects cancer in the peritoneum and other sites, with the entire participation lasting a few weeks around the imaging and follow-up visits.