drugset / Trial / NCT06769828
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
NaSingle-groupOpen-labelDiagnostic
Summary
This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.
Timeline
- Start
- 2025-02-01
- Primary completion
- 2026-04-14
- Completion
- 2026-04-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ga68-FAPI-46 | Diagnostic / imaging agent | 1.8 mbq/kg | Intravenous |
| Subject | Ga68-FAPI-46 | Diagnostic / imaging agent | 2.2 mbq/kg | Intravenous |