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NOT YET RECRUITING
NCT07705074
PHASE1/PHASE2

FAPI PET Imaging - An Exploratory Study

Sponsor: Martin Huellner

View on ClinicalTrials.gov

Summary

This study is testing a new imaging tracer called \[18F\]FAPI-74 with PET scans. Researchers want to find out how well this tracer shows certain diseases in the body, including several types of cancer and some non-cancer conditions like fibrosis and sarcoidosis. \[18F\]FAPI-74 attaches to a protein found on cells that are active in tumors and areas of scarring or inflammation. This may help doctors see these areas more clearly than with imaging methods used today, especially in diseases where current scans do not work well. People who join this study will get one injection of the tracer into a vein, then have one PET/CT or PET/MR scan. This takes about 2 hours in total. Researchers will compare the results with imaging the participant already had as part of their regular care, such as other PET scans, CT, or MRI. No extra treatment is given, and no other visits are needed. The study will take place at 5 hospitals in Switzerland and plans to include about 770 adults with a confirmed or suspected diagnosis of one of the conditions being studied. The main goal is to see how clearly the tracer shows up on the scan. Researchers will also look at whether this new scan changes how confident doctors feel about a diagnosis, or changes the patient's treatment plan.

Official title: FAPI PET Imaging - a Multicentric Exploratory Evaluation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

770

Start Date

2026-08

Completion Date

2029-09

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

DRUG

[18F]FAPI-74 PET/CT

18F\]FAPI-74 is a fluorine-18 labelled, quinoline-based small-molecule inhibitor targeting fibroblast activation protein (FAP), a transmembrane glycoprotein selectively expressed on cancer-associated fibroblasts and in fibrotic/inflammatory tissue. Each participant receives a single intravenous slow-bolus injection (5-15 seconds) of approximately 250 MBq (permissible range 200-300 MBq), followed by a 45-60 minute uptake period and one PET/CT or PET/MR acquisition. The product is manufactured under GMP at the USZ Radiopharmacy using precursor material supplied by SOFIE Biosciences. Unlike clinically established PET tracers (e.g., FDG, PSMA-ligands), \[18F\]FAPI-74 is not yet authorized in Switzerland and is administered exclusively within this investigational protocol for diagnostic evaluation purposes only.

Locations (5)

Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Hôpitaux Universitaires de Genève (HUG)

Geneva, Canton of Geneva, Switzerland

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Clinique de Genolier

Genolier, Canton of Vaud, Switzerland

Department for Nuclear Medicine, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland