Taking people in BelgiumPhase 2/3
Tests a PET scan tracer for finding pancreatic and stomach or esophageal cancers
Tests a PET scan tracer to detect pancreatic and stomach or esophageal cancers.
Key facts
- Who runs it
- UZ Leuven
- Where
- Edegem, Gent, and Leuven, BelgiumSee the 3 sites
- Trial code
- Registry title
- FAPIDO
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 109 people, planned
- Started
- 14 Feb 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Record updated
- 27 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed oesophagogastric or pancreatic cancer, and adults with a proven cancer and a clinically challenging situation. All join a PET/CT imaging study with [18F]AlF-FAPI-74.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Oesophagogastric adenocarcinoma: newly diagnosed, cT1-4N0-3M0. Pancreatic ductal adenocarcinoma: newly diagnosed, cT1-4N0-2M0-1, not upfront resectable. Other cancers: proven cancer with unexplained symptoms, complaints, or blood or imaging findings.
- Earlier treatment
- The record names no required earlier treatment. The summary describes treatment-naïve, newly diagnosed patients. A [18F]FDG PET/CT must have been done or be planned within 4 weeks. For pancreatic cancer, conventional abdomen CT or MRI within 4 weeks can replace it.
Main reasons for not taking part
- Pregnant or breast-feeding women, or women who intend to become pregnant
- Women who can have children and do not use highly effective contraception
- Pancreatic cancer that can be removed by surgery right away
- Taking part in a clinical study in the last 12 months with radiation exposure greater than 1 mSv
- Cannot understand the study or cannot go through all study procedures
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Belgium
- Antwerp University HospitalEdegem, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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.
- Plain-language title
- Tests a PET scan tracer for finding pancreatic and stomach or esophageal cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 27 October 2026