nctId: NCT06275477 id: 29BRC23.0029 briefTitle: 68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases acronym: PARADISE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-21 date: 2026-04-21 date: 2024-02-23 date: 2024-02-23 name: University Hospital, Brest class: OTHER briefSummary: 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. conditions: Inflammatory Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single-center, descriptive and analytical pilot study, which will be implemented in 13 distinct and independent populations of patients with chronic inflammatory and/or fibrosing disease. primaryPurpose: DIAGNOSTIC masking: NONE count: 390 type: ESTIMATED name: 68Ga-FAPI46 measure: PET uptake intensity measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga] Ga-FAPI PET/CT parameters evolution measure: [68Ga] Ga-FAPI PET/CT parameters evolution measure: [68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison measure: [68Ga] Ga-FAPI PET/CT kinetic measure: [68Ga] Ga-FAPI PET/CT kinetic measure: [68Ga] Ga-FAPI PET/CT kinetic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False