NCT05262855

Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma

A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: SOFIE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second \[68Ga\]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

Conditions

• PDAC - Pancreatic Ductal Adenocarcinoma
• FAP

Interventions

Type	Name	Description
DRUG	[68Ga]FAPI-46	\[68Ga\]-FAPI-46 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma (PDAC).

Timeline

• Start date: 2022-05-02
• Primary completion: 2025-03-07
• Completion: 2025-11-04
• First posted: 2022-03-02
• Last updated: 2026-01-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study