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A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Pancreatic Ductal Adenocarcinoma

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Trial Profile

A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Pancreatic Ductal Adenocarcinoma

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2025

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At a glance

  • Drugs Fluorine-18 FAPI 74 (Primary)
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Diagnostic use; Registrational
  • Acronyms FAPI-PRO
  • Sponsors SOFIE

Most Recent Events

  • 18 Nov 2025 Planned initiation date changed from 15 Dec 2025 to 23 Dec 2025.
  • 21 Oct 2025 New trial record
  • 01 Oct 2025 According to a SOFIE Biosciences media release, company Alignment with FDA on study design to advance two Phase 3 Clinical trials in gastroesophageal cancers (FAPI-GO) and PDAC (FAPI-PRO), with [18F]FAPI-74.

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