NCT06782412RecruitingPhase 2/3
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: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 109 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 6 Feb 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- KU Leuven
- NCT number
- NCT06782412
- EudraCT number
- 2024-512059-19
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 109
- From 6 Feb 2025 to the primary completion date, Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov 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.
- Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients.
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.
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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Antwerp (UZA) Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| University Hospital Ghent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.