FAPI PET Imaging - An Exploratory Study

Sponsor
Martin Huellner
Study ID
NCT07705074
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]FAPI-74 PET/CT — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
770 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [18F]FAPI-74 PET Imaging
    Participants receive a single intravenous injection of approximately 250 MBq \[18F\]FAPI-74 (fluorine-18 labelled FAP-targeted PET radiotracer), followed by one PET/CT or PET/MR scan performed 45-60 minutes post-injection. For PET/CT acquisitions, a low-dose CT is performed for attenuation correction and anatomical localization. No therapeutic intervention, randomization, or repeat tracer administration is involved. Uptake and diagnostic image quality are assessed qualitatively by a nuclear medicine physician from the local study team. Findings are compared with each participant's own previously acquired standard-of-care imaging (e.g., FDG-PET/CT, PSMA-PET/CT, CT, or MRI), which serves as the reference standard rather than a concurrent study arm. Total participation time is approximately 2 hours on a single study day.

Primary Outcome Measure

Diagnostic Interpretability and Uptake Classification of [18F]FAPI-74 PET Imaging [ Time Frame: At the time of [18F]FAPI-74 PET/CT or PET/MR image acquisition and interpretation, performed 45-60 minutes after tracer injection, on the single study visit day. ]

Central Contacts

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