NCT06782412

Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 109 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the project is to demonstrate superior detection ratio of \[18F\]AlF-FAPI-74 PET/CT compared to \[18F\]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \[18F\]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.

Conditions

• Oesophageal Cancer
• Gastric Cancer
• Pancreatic Ductal Adenocarcinoma
• FAP
• Oncology
• Oncologic Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[18F]AlF-FAPI-74 PET/CT	A \[18F\]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the \[18F\]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second \[18F\]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second \[18F\]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) \[18F\]AlF-FAPI-74 PET/CT, before the final surgery.

Timeline

• Start date: 2025-02-06
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-01-17
• Last updated: 2025-02-07

Locations

3 sites across 1 country: Belgium