FAPIDO

Trial details

Who runs it

UZ Leuven

Trial code

EU 2024-512059-19-00

Record updated

2026. október 27.

Original description

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. It is a prospective, non-randomized, multicenter, multi-cohort, interventional phase II/III trial.Read full original descriptionShow less

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.

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. It is a prospective, non-randomized, multicenter, multi-cohort, interventional phase II/III trial.

Inclusion: Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; Age 18 or older; For OGA: New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma. + Patient underwent a [18F]FDG PET/CT or is planned to have one in the following 4 weeks. + TNM classification: cT1-4N0-3M0; For PDAC: New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma. + Patient underwent a [18F]FDG PET/CT or is planned to have one in the following 4 weeks or patient underwent/is planned to have conventional staging with (upper) abdomen CT or (upper) abdomen MRI in the following 4 weeks. + TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients; For the oncology patients with a clinically challenging situation: Histologic or cytologic proven diagnosis of a malignancy. + Patient underwent a [18F]FDG PET/CT of is planned to have one in the following 4 weeks. + Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.

Exclusion: Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial; Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv; Any disorder or condition, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol; Participant is mentally or legally incapacitated, doesn’t understand the study design or is not willing or capable to undergo all study-specific procedures; 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; For PDAC: Patient is upfront resectable.

EU CTIS 2024-512059-19-00