RecruitingNot ApplicableNCT06275477

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

Sponsor

University Hospital, Brest

Enrollment

390 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

Inflammatory Disease

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria6

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).

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Interventions

DIAGNOSTIC_TEST68Ga-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).