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

Recruiting now · Phase 2/Phase 3

Conditions studied: Oesophageal Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma, FAP, Oncology, Oncologic Disorders

In brief

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.

Key facts

Study ID: NCT06782412
Run by: KU Leuven
People needed: 109
Starts: 2025-02-06
Expected to finish: 2027-12-01
Last updated by the study team: 2025-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
Participant has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients.

Where it is running

University Hospital Ghent — Ghent, Belgium (enrolling)
UZ Leuven — Leuven, Belgium (enrolling)
University Hospital Antwerp (UZA) — Edegem, Belgium

Full record on ClinicalTrials.gov

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