RecruitingPhase 2Phase 3NCT06782412

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


Sponsor

KU Leuven

Enrollment

109 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new PET imaging tracer called [18F]AlF-FAPI-74, which can help detect certain proteins on cancer cells. Researchers want to compare how well this new scan finds cancer tissue compared to the standard FDG-PET scan, especially in stomach, esophageal, and pancreatic cancers. **You may be eligible if...** - You are 18 or older - You have a newly confirmed diagnosis of esophagogastric adenocarcinoma or pancreatic ductal adenocarcinoma (or another cancer where standard imaging is inconclusive) - You have already undergone a standard FDG-PET scan or CT/MRI staging - Your cancer has not yet been treated **You may NOT be eligible if...** - Your cancer has already been surgically removed and is fully resectable without complications - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.


Locations(3)

University Hospital Antwerp (UZA)

Edegem, Belgium

University Hospital Ghent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

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NCT06782412


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