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
Key facts
- Where
- Edegem, Ghent, and Leuven, BelgiumSee the 3 sites
- Phase
- Phase 2/3
Where in Belgium
- University Hospital Antwerp (UZA)Edegem, BelgiumNot yet recruiting
- University Hospital GhentGhent, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
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?
Trial details
- Who runs it
- KU Leuven
- Trial code
- NCT06782412
- Record updated
- 6 November 2026
- 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.Read full original descriptionShow less
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.
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; New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma; Patient underwent a [18F]FDG PET/CT; TNM classification: cT1-4N0-3M0; 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 pancreatic ductal adenocarcinoma; Patient underwent a [18F]FDG PET/CT or conventional staging with CT or MRI; TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients; Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; Age 18 or older; Histologic or cytologic proven diagnosis of a malignancy; Patient underwent a [18F]FDG PET/CT; 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 has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients; 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.