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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

February 6, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Oesophageal CancerGastric CancerPancreatic Ductal AdenocarcinomaFAPOncologyOncologic Disorders
Interventions
DIAGNOSTIC_TEST

[18F]AlF-FAPI-74 PET/CT

A \[18F\]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the \[18F\]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second \[18F\]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second \[18F\]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) \[18F\]AlF-FAPI-74 PET/CT, before the final surgery.

Trial Locations (3)

2650

NOT_YET_RECRUITING

University Hospital Antwerp (UZA), Edegem

3000

RECRUITING

UZ Leuven, Leuven

9000

RECRUITING

University Hospital Ghent, Ghent

All Listed Sponsors
collaborator

University Hospital, Ghent

OTHER

collaborator

University Hospital, Antwerp

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

Kom Op Tegen Kanker

OTHER

lead

KU Leuven

OTHER