protocolSection identificationModule nctId: NCT06275477, orgStudyIdInfo id: 29BRC23.0029, briefTitle: 68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases, acronym: PARADISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-21, completionDateStruct date: 2026-04-21, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule 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., conditionsModule conditions: Inflammatory Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-FAPI46, outcomesModule primaryOutcomes measure: PET uptake intensity, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT parameters evolution, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT parameters evolution, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT kinetic, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT kinetic, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT kinetic, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False