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A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Trial Profile

A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Feb 2026

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At a glance

  • Drugs Fluorine-18 FAPI 74 (Primary)
  • Indications Cholangiocarcinoma; Colorectal cancer; Gastric cancer; Gastrointestinal cancer; Liver cancer; Pancreatic cancer
  • Focus Diagnostic use
  • Acronyms 18F-FAPI-74 GI
  • Sponsors SOFIE

Most Recent Events

  • 22 Jan 2026 Actual primary completion date changed from 1 Jul 2025 to 30 Jun 2025.
  • 01 Oct 2025 Primary endpoint (Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.) has been met, according to a SOFIE Biosciences media release.
  • 01 Oct 2025 Results presented in a SOFIE Biosciences media release.

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