68Gallium-FAPI46 PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases

NCT06275477 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Brest

Phase

Not applicable

Started

2025-03-13

Last updated

2026-06-16

Condition(s) studied

Inflammatory Disease

Investigational drug(s) / intervention(s)

68Ga-FAPI46

68Ga-FAPI46: Depending on the situation, it is planned that this evaluation will be transversal (performing \[68Ga\] Ga-FAPI PET/CT at baseline) or longitudinal (performing \[68Ga\] Ga-FAPI PET/CT at baseline and at 3/6 months for patients benefiting from an intensification of therapeutic management at inclusion).

Study summary

This single-center pilot study is designed to explore the preliminary utility of the \[68Ga\] Ga-FAPI imaging agent in positron emission tomography (PET) combined with computed tomography (CT) for a range of chronic inflammatory and fibrosing diseases. The study focuses on the potential of \[68Ga\] Ga-FAPI, a novel radiotracer targeting Fibroblast Activation Protein (FAP), to improve diagnostic accuracy in various medical conditions. Thirteen distinct clinical situations have been selected for this investigation, including rheumatoid arthritis, liver fibrosis, and systemic lupus, among others. This approach aims to ascertain the value of further clinical development in each area and refine the use of this imaging modality in routine care for both initial evaluation and ongoing monitoring of these diseases.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient aged 18 or over. * Affected by one of the pathologies concerned by the study (see Table 4) * Satisfying the consensus classification criteria for the pathology (Table 3). * Satisfying the corresponding clinical situation (Table 3). * Negative urine pregnancy test for women of childbearing age. * Affiliated with or benefiting from social security. * Informed consent (personally dated and) signed by the participant or any representatives (impartial witness/trusted person). Exclusion Criteria: * Patients unable to consent. * Incapacitated adults. * Pregnant or breastfeeding women. * Patients refusing to participate in research. * Known active cancer. * Women of childbearing potential unwilling to use appropriate contraception (definitions given in Annex 1).

Primary outcome measure(s)

PET uptake intensity — Month 0
Describe the sites and intensity of fixation of \[68Ga\] Ga-FAPI PET/CT measured by the Standardized uptake value (SUV) max on the examination performed at M0 in the 13 targeted chronic inflammatory and/or fibrosing diseases.

Trial sites (1)

Facility	City	Region	Status
Chu Brest	Brest	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06275477 on ClinicalTrials.gov ↗ ← All trials in France