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 probes 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 probes 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 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 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 studying the effects and safety of alternating two chemotherapy treatments, gemcitabine plus nab-paclitaxel GnP and modified FOLFIRINOX mFOLFIRINOX, in patients with borderline resectable pancreatic ductal adenocarcinoma BR-PDAC. These treatments are FDA-approved for this condition, and alternating them aims to improve how well the cancer responds to therapy, increase the chance of successful tumor removal, and reduce the risk of cancer recurrence. Participants will receive GnP on days 1, 8, and 15 during cycles 1 and 3, and mFOLFIRINOX on days 1 and 15 during cycles 2 and 4, with each cycle lasting 28 days. This neoadjuvant chemotherapy is given before surgery, following recommendations by treating physicians. The study is a single-group, phase 2 clinical trial that evaluates this alternating treatment approach. During the study, participants will undergo contrast-enhanced CT scans of the chest, abdomen, and pelvis, as well as regular assessments of tumor response, surgical resection outcomes, and survival rates for up to one year. Researchers will monitor safety, treatment completion, dose changes, and cancer recurrence. The main measurement is one-year event-free survival. Participation lasts until surgery and follow-up evaluations, with data collected to assess the effectiveness and safety of the alternating chemotherapy regimen.

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 12a 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 PETCT 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 PETMRI 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 PETMRI. Participants give informed consent and receive imaging based on clinical need throughout their follow-up.

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 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-3 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 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.