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

Recruiting Phase 2 Phase 3 Interventional Study
Oesophageal Cancer Gastric Cancer Pancreatic Ductal Adenocarcinoma FAP Oncology Oncologic Disorders
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Diagnostic
Participants needed
109 (estimated)
Sponsor
KU Leuven · Other
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About This Trial
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 patient…
Trial Locations
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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 underwe…
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