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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKU Leuven

About this trial

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 criteria

Qualifiers

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.

Age 18 or older.

New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.

Patient underwent a [18F]FDG PET/CT.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • [18F]AlF-FAPI-74 PET/CT

Treatment groups

109 Participants
are divided into 3 treatment groups

Sponsors and collaborators

KU Leuven

Lead sponsor

University Hospital, Ghent

Collaborator

University Hospital, Antwerp

Collaborator

Universitaire Ziekenhuizen KU Leuven

Collaborator

Kom Op Tegen Kanker

Collaborator