This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of \[68Ga\]BED003 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.
Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [68Ga]BED003 administration.
Participants administered any radioisotope within 5 physical half-lives prior to [68Ga]BED003 administration.
Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
Participants who have recently received any other contrast agent (< 24 hours for IV agents and < 5 days for oral agents) before the day of [68Ga]BED003 administration.
Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
Blue Earth Diagnostics
Lead sponsor
Medpace, Inc.
Collaborator