FAPI PET Imaging - An Exploratory Study

NCT07705074 | Not Yet Recruiting Phase 1

• 1 other identifier: BASEC 2026-OO454
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 5

Brief 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)

Keywords

[18F]FAPI-74; Fibroblast Activation Protein; FAP-targeted imaging; PET/CT; Radiotracer; Diagnostic imaging; Multicentric study; Radiopharmaceutical; FAPI; FAPI-74; nuclear medicine; University Hospital Zurich; swiss multicenter trial; Cancer-associated fibroblast imaging; oncologic imaging; non-oncologic imaging

Outcome Measures

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.

  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 (2)

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

  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

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

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

Study Arms (1)

[18F]FAPI-74 PET Imaging

EXPERIMENTAL

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.

Drug: [18F]FAPI-74 PET/CT

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.

Also known as: FAPI PET

[18F]FAPI-74 PET Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Inability to understand the study information, for example due to language barriers.
• Subjects incapable of judgment (e.g. individuals under legal or medical incapacity).
• Participants scheduled for PET/MR imaging: Presence of MRI-incompatible metallic implants, electronic devices (e.g. pacemakers, cochlear implants), or other ferromagnetic foreign bodies.

Sponsors & Collaborators

• Martin Huellner: lead
• University Hospital, Zürich: collaborator

Study Sites (5)

Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Location

Hôpitaux Universitaires de Genève (HUG)

Geneva, Canton of Geneva, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Location

Clinique de Genolier

Genolier, Canton of Vaud, Switzerland

Location

Department for Nuclear Medicine, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Sarcoidosis; Thyroid Neoplasms; Breast Neoplasms; Carcinoma, Hepatocellular; Stomach Neoplasms; Pancreatic cancer, adult; Carcinoma, Transitional Cell; Multiple Myeloma; Plasmacytoma; Mesothelioma; Liver Cirrhosis; Endometriosis; Disease; Pulmonary Fibrosis; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Immunoproliferative Disorders; Adenoma; Neoplasms, Mesothelial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Martin Hüllner, Prof. Dr. med.

  Department for Nuclear Medicine, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Hüllner, Prof. Dr. med.

CONTACT

0041442552580; martin.huellner@usz.ch

Patrick Perron, Masters Degree

CONTACT

0041442552827; patrick.perron@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CH (5)