NCT06782412 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
| NCT ID | NCT06782412 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | KU Leuven |
| Condition | Oesophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 109 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 109 participants in total. It began in 2025-02-06 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria OGA: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Age 18 or older. 3. New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma. 4. Patient underwent a \[18F\]FDG PET/CT. 5. TNM classification: cT1-4N0-3M0 Inclusion Criteria PDAC: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Age 18 or older. 3. New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma. 4. Patient underwent a \[18F\]FDG PET/CT or conventional staging with CT or MRI. 5. TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients. Inclusion Criteria Clinically challenging cohort: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Age 18 or older. 3. Histologic or cytologic proven diagnosis of a malignancy. 4. Patient underwent a \[18F\]FDG PET/CT. 5. Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings. Exclusion Criteria: 1. Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures. 2. Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol. 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial. 4. 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). 5. 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. 6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv. 7. Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients.
Frequently Asked Questions
Who can join the NCT06782412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oesophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06782412 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06782412 currently recruiting?
Yes, NCT06782412 is actively recruiting participants. Visit ClinicalTrials.gov or contact KU Leuven to inquire about joining.
Where is the NCT06782412 trial being conducted?
This trial is being conducted at Edegem, Belgium, Ghent, Belgium, Leuven, Belgium.
Who is sponsoring the NCT06782412 clinical trial?
NCT06782412 is sponsored by KU Leuven. The trial plans to enroll 109 participants.
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