Pancreatic Cancer

Researchers are evaluating the safety and effectiveness of a new molecular probe called 18F-FAPI-YQ104, which targets fibroblast activation protein (FAP), for early tumor diagnosis. This observational study focuses on patients with lung cancer, pancreatic cancer, neuroendocrine tumors, and thyroid cancer. The goal is to verify how well this probe works in detecting tumors during clinical use. Participants will receive an intravenous injection of the 18F-FAPI-YQ104 probe followed by a PET-CT examination to capture detailed images of tumor lesions. The study will observe the probe's uptake in tumor sites, measured by SUVmax values 60 minutes after administration. No additional treatment is given; instead, the study monitors the imaging results to assess the probe's diagnostic potential. During the study, participants will undergo PET-CT scans and other imaging tests such as CT or MRI. Researchers will evaluate the images to measure tumor activity and probe uptake. Safety assessments include checking kidney and liver function, blood counts, and monitoring for allergic reactions. The study will last from April 2025 to March 2026 and includes adults aged 18 to 75 years who have confirmed tumors and meet health criteria.

Researchers are evaluating a new PET imaging tracer called [18F]FAPI-74 to detect cancer by targeting the fibroblast-activation protein (FAP) found in cancer-associated fibroblasts. This study aims to compare [18F]FAPI-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, pheochromocytoma/paraganglioma, 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 [18F]FAPI-74 before undergoing PET/CT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by [18F]FAPI-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 [18F]FAPI-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 evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PET/CT 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, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT 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 PET/CT 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 studying the effects and safety of alternating two neoadjuvant chemotherapy treatments—modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP)—in patients with borderline resectable pancreatic adenocarcinoma. Both treatments are FDA-approved and commonly used, and this study aims to see if alternating them before surgery can improve tumor removal, treatment response, and reduce the chance of cancer returning. Participants will receive these chemotherapy drugs in a specific schedule: GnP is given on days 1, 8, and 15 during cycles 1 and 3 (each cycle lasting 28 days), while mFOLFIRINOX is administered on days 1 and 15 during cycles 2 and 4. This alternating treatment is given before surgery, following recommendations from their treating physician. The study is a phase 2 clinical trial sponsored by Dartmouth-Hitchcock Medical Center. During the study, participants will have imaging scans such as contrast-enhanced CT scans and undergo evaluations of their physical health and tumor response. Researchers will monitor safety, treatment completion, need for dose changes, surgery rates, and survival outcomes over one year. Key measurements include one-year event-free survival and recurrence-free survival after surgery, among others. The total participation length varies but includes assessments before and after chemotherapy and surgery.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract (GIT) cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein (FAP) expression in tumor samples. This Phase 1/2a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PET/CT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a diverse group of tumors arising from endocrine cells in the digestive tract. Researchers are evaluating the use of 68Ga-DOTATOC PET imaging, combined with MRI or CT scans, to improve diagnosis and prognosis for patients with GEP-NETs. This study focuses on assessing the accuracy and predictive value of these imaging techniques over a period of 10 years. Patients who qualify will undergo 68Ga-DOTATOC PET as part of their standard diagnostic process. This PET scan may be performed with MRI or CT, with PET/MRI conducted on a 3.0T time-of-flight scanner approximately 60 minutes after injection of the tracer. The study will include patients during their regular clinical evaluation without additional experimental treatments. Participants will be monitored through their imaging results collected during routine care. The main outcome measured is the diagnostic accuracy of the imaging over 10 years. The study aims to gather important information on how these imaging methods can predict disease progression and mortality while minimizing radiation exposure, especially with the use of PET/MRI. Participants give informed consent and receive imaging based on clinical need throughout their follow-up.

Researchers are studying a combination treatment involving 9-ING-41 (elraglusib), retifanlimab, and modified FOLFIRINOX chemotherapy in patients with advanced pancreatic adenocarcinoma who have not received prior systemic therapy for their advanced disease. This Phase 1b study aims to evaluate the safety, tolerability, and potential anti-tumor activity of these combined therapies, as 9-ING-41 inhibits GSK-3β which may enhance immune response when combined with a PD-1 inhibitor like retifanlimab. The study builds on previous positive safety and efficacy data for each agent separately but seeks to understand their combined effects. The treatment involves chemotherapy with oxaliplatin, leucovorin, irinotecan, and 5-FU administered every 14 days, retifanlimab given by IV infusion at 500 mg on day 1 of every other cycle, and 9-ING-41 given intravenously twice weekly for the first four cycles then weekly thereafter. The study starts with a safety lead-in cohort of 6 patients to assess dose-limiting toxicities and may adjust doses accordingly before expanding to a larger group up to 12 patients total. This combination has not been previously tested together in humans. Participants will undergo scheduled visits with laboratory tests and imaging to monitor treatment safety and tumor response. Researchers will track dose-limiting toxicities within 28 days of treatment start and measure disease control rates, response rates, progression-free survival, overall survival, and treatment-related adverse events over months to years. The study includes detailed monitoring of lab function, performance status, and tumor measurements to assess outcomes and safety during follow-up periods up to 42 months.

Researchers are studying a new imaging agent called [18F]FPyQCP in a Phase 1/2 trial to evaluate its safety, radiation exposure, and how well it detects several cancers: colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of [18F]FPyQCP followed by a positron emission tomography (PET)/computed tomography (CT) scan during a designated imaging visit. The study includes two groups: Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well [18F]FPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.

Researchers are evaluating the clinical use of [68Ga]Ga-FAPI-46 PET/CT imaging in patients with pancreatic or bile duct cancer. This study aims to find the best timing and scan protocol, test the repeatability of the scan results, and assess the accuracy of this imaging method to detect pancreatic cancer and monitor chemotherapy effects. The study is divided into three parts, with each participant joining only one part. In part A, participants will have one [68Ga]Ga-FAPI-46 PET/CT scan and receive two venous cannulas and one arterial cannula. Part B involves two scans with a venous cannula for each. Part C includes two scans with venous cannulas and focuses on patients eligible for neoadjuvant therapy before surgery. The study evaluates the tracer's pharmacokinetics, repeatability, and diagnostic accuracy. Participants will undergo PET/CT scans and have cannulas placed as needed. Researchers will collect blood activity measurements, plasma to blood ratios, and semi-quantitative tracer uptake data. They will assess repeatability, diagnostic accuracy, and therapy response monitoring over three months. Safety and agreement between imaging and pathology will also be evaluated during and after scans.

Researchers are conducting an open-label, multi-site, multi-cohort phase 1/2 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 combined with anti-cancer therapies in participants with advanced solid tumors, including mesothelioma, pancreatic cancer, and advanced non-small cell lung cancer (NSCLC). The study aims to understand how ODM-212 works alongside other treatments in these serious cancers. The trial has two parts: dose escalation and dose expansion/optimization. Participants receive ODM-212 tablets along with other anti-cancer drugs depending on their cancer type. For mesothelioma, ODM-212 is combined with ipilimumab and nivolumab given intravenously on specific schedules. For pancreatic cancer, it is combined with gemcitabine and nab-paclitaxel administered intravenously in cycles. For NSCLC with a KRAS G12C mutation, ODM-212 is combined with sotorasib taken orally daily in 21-day cycles. Participants will be closely monitored throughout the study, with evaluations of side effects, dose-limiting toxicities, and adverse events tracked on average for two years. The research team will collect tumor tissue samples, monitor treatment adherence, and perform assessments to measure disease status and treatment effects. Safety will be carefully checked with exams, ECGs, and laboratory tests. The study is planned to continue through 2029, with ongoing visits and follow-ups as part of participant involvement.