Actively Recruiting
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
Led by KU Leuven · Updated on 2025-02-07
109
Participants Needed
3
Research Sites
146 weeks
Total Duration
On this page
Sponsors
K
KU Leuven
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria OGA:
- 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
Inclusion Criteria PDAC:
- 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.
Inclusion Criteria Clinically challenging cohort:
- 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 Criteria:
- Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
- Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
- 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.
- Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
- Participant has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University Hospital Antwerp (UZA)
Edegem, Belgium, 2650
Not Yet Recruiting
2
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
3
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here