FAPI PET Imaging - An Exploratory Study

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMartin Huellner

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent obtained and documented by the participant's signature.

Age ≥18 years at the time of consent.

Clinically established or suspected diagnosis or recurrence of an oncologic or non-oncologic disease as defined in chapter 7.1 of study protocol.

Availability of standard-of-care imaging (e.g., clinically established PET tracer or anatomical imaging such as CT/MRI) to allow comparative evaluation.

Disqualifiers

Severe claustrophobia that would preclude PET imaging.

Inability to remain still for the duration of the PET/MR examination.

Current pregnancy or breastfeeding; no pregnancy test is required for women who are postmenopausal for ≥12 months or have undergone surgical sterilization, bilateral oophorectomy, or hysterectomy.

Previous hypersensitivity reactions to radiotracer administration

Trial design

Treatments tested in this trial

  • [18F]FAPI-74 PET/CT

Treatment groups

770 Participants
are divided into 1 treatment group

Sponsors and collaborators

Martin Huellner

Lead sponsor

University of Zurich

Sponsor institution

University Hospital, Zürich

Collaborator