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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
University Hospital Antwerp (UZA)
NOT_YET_RECRUITING
Edegem
University Hospital Ghent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2027-12
Participants
Target number of participants: 109
Treatments
Experimental: Oesophagogastric adenocarcinoma (OGA)
Experimental: Pancreatic ductal adenocarcinoma (PDAC)
Experimental: Clinically challenging situations
Related Therapeutic Areas
Sponsors
Leads: KU Leuven
Collaborators: Kom Op Tegen Kanker, Universitaire Ziekenhuizen KU Leuven, University Hospital, Antwerp, University Hospital, Ghent

This content was sourced from clinicaltrials.gov