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.
Single group
[68Ga]BED003
DrugPositron emission tomography (PET)/computed tomography (CT) imaging
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Assess the diagnostic performance of \[68Ga\]BED003 in the peritoneum.
Further assess the diagnostic performance of [68Ga]BED003.
Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with \[68Ga\]BED003 PET/CT compared to composite SOT and participant and region level detection rates
Semiquantitative assessment of [68Ga]BED003 tumour uptake.
Standardised uptake values and tumour-to-background ratios.
Evaluate the safety and tolerability of [68Ga]BED003.
Incidence and severity of adverse events using CTCAE version 5.0.
Confirm optimal timing of imaging following [68Ga]BED003 injection (first 6 participants).
Comparison of tumour-to-background ratios and reader assessments of diagnostic quality.
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Blue Earth Diagnostics
Lead sponsor
Medpace, Inc.
Collaborator
