drugset / Trial / NCT06769828

Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA

NCT06769828 ↗

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

EvaluationDrugModalityDoseRoute
Subject Ga68-FAPI-46 Diagnostic / imaging agent 1.8 mbq/kg Intravenous
Subject Ga68-FAPI-46 Diagnostic / imaging agent 2.2 mbq/kg Intravenous

Indications