This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
Eastern Cooperative Oncology Group performance status ≤ 2.
Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
Participants administered any radioisotope within 5 physical half-lives prior to [18F]FPyQCP administration.
Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [18F]FPyQCP administration.
Participants who have recently received any other contrast agent (< 24 hours for intravenous agents and < 5 days for oral agents) before the day of [18F]FPyQCP administration.
Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
Blue Earth Diagnostics
Lead sponsor
Medpace, Inc.
Collaborator