2024-512059-19-00RecruitingPhase 2/3
FAPIDO
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 109 (estimated)
- First submitted
- 2 Oct 2024
- Start date
- 14 Feb 2025
- Lead sponsor
- UZ Leuven
- Diseases
- Pancreatic cancer
- EU CT number
- 2024-512059-19-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 109
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any disorder or condition, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent | Gent | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.