FAPI PET Imaging - An Exploratory Study

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.

Conditions

• Thyroid Pathology
• Head and Neck Cancer (H&N)
• Sinonasal Tract Tumor
• Sarcoidosis
• Thyroid Cancer
• Breast Cancer
• Hepatocellular Carcinoma (HCC)
• Gastric Cancer (GC)
• Pancreatic Cancer, Adult
• Urothelial Carcinoma (UC)
• Multiple Myeloma or Plasmacytoma
• Mesothelioma
• Hepatic Fibrosis
• Endometriosis (Diagnosis)
• Lung Fibrosis
• Neck Node Metastasis
• Prostate Cancer (CRPC)

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.

Sponsors & Collaborators

• University Hospital, Zürich

  collaborator OTHER

• Martin Huellner

  lead OTHER

Principal Investigators

• Martin Hüllner, Prof. Dr. med. · Department for Nuclear Medicine, University Hospital Zurich

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2029-09-30

Completion

2029-09-30

Countries

• Switzerland

Study Locations