Phase 12 Study of 18FFPyQCP PET Imaging to Detect Fibroblast Activation Protein in Various Cancers

What this Trial Is About

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.

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications