Clinical trial · Interventional
FAPI PET Imaging - An Exploratory Study
FAPI PET Imaging - a Multicentric Exploratory Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Endometriosis (Diagnosis) | — | UNRESOLVED | — |
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer (H&N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
| Hepatic Fibrosis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Lung Fibrosis | — | UNRESOLVED | — |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]FAPI-74 PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]FAPI-74 PET Imaging
- description
- 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.
- interventionNames
- Drug: [18F]FAPI-74 PET/CT
Primary outcomes (1)
- measure
- Diagnostic Interpretability and Uptake Classification of [18F]FAPI-74 PET Imaging
- timeFrame
- 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.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available