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FAPI PET Imaging - An Exploratory Study

ConditionsThyroid PathologyHead and Neck Cancer (H&N)Sinonasal Tract TumorSarcoidosisThyroid CancerBreast CancerHepatocellular Carcinoma (HCC)Gastric Cancer (GC)Pancreatic Cancer, AdultUrothelial Carcinoma (UC)Multiple Myeloma or PlasmacytomaMesotheliomaHepatic FibrosisEndometriosis (Diagnosis)Lung FibrosisNeck Node MetastasisProstate Cancer (CRPC)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • [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.

Treatment groups

770 Participants
are divided into 1 treatment group
Group A: [18F]FAPI-74 PET ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic Interpretability and Uptake Classification of [18F]FAPI-74 PET Imaging

Qualitative assessment of \[18F\]FAPI-74 uptake by a local nuclear medicine physician, classified as FAPI-positive or FAPI-negative in target lesions or disease-specific regions. Overall diagnostic image quality will additionally be rated using a 4-point scale: fully diagnostic, almost fully diagnostic, diagnostically limited, or non-diagnostic. The primary analysis will report the proportion of participants with diagnostically interpretable \[18F\]FAPI-74 images, per indication and pooled across indications.

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.

Secondary outcomes

1

Lesion-Wise Comparison of [18F]FAPI-74 Uptake with Standard-of-Care Reference Imaging

Qualitative and semi-quantitative comparison of \[18F\]FAPI-74 uptake with each participant's available standard-of-care reference imaging (e.g., FDG-PET/CT, PSMA-PET/CT, or morphological imaging such as CT/MRI), performed on a lesion-wise basis. Comparative ratings will classify \[18F\]FAPI-74 findings as providing more, comparable, or less diagnostic information relative to the reference imaging. Where available, histopathology or composite clinical/imaging follow-up will serve as the reference standard for calculating sensitivity, specificity, and positive predictive value per indication.

Time frame
At the time of [18F]FAPI-74 image interpretation, compared against each participant's most recent standard-of-care reference imaging obtained as part of routine clinical care
2

Change in Diagnostic Confidence and Clinical Management Following [18F]FAPI-74 Imaging

Change in diagnostic confidence and clinical management recommendations, determined by comparing physician assessments performed before versus after review of \[18F\]FAPI-74 imaging. Diagnostic confidence will be rated on a defined scale; management change will be recorded as a binary indicator (yes/no), with the type of change categorized (e.g., additional biopsy recommended, therapy switch, change in staging). Clinical impact of \[18F\]FAPI-74 findings will additionally be classified as major impact (change in diagnosis or management), minor impact (additional findings not altering management), or no impact.

Time frame
Diagnostic confidence and management recommendations assessed immediately before and after review of [18F]FAPI-74 imaging, on the single study visit day.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Martin Huellner

Lead sponsor

University of Zurich

Sponsor institution

University Hospital, Zürich

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: