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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Disease
• Intervention / Treatment: Diagnostic test: 68Ga-FAPI46

Detailed Description

[68Ga] Ga-FAPI is an innovative radiotracer in positron emission tomography (PET) coupled to scanner (CT: computed tomography). It targets the membrane glycoprotein FAP (Fibroblast Activation Protein), a specific surface marker of activated fibroblasts, these constituting one of the main populations of the tumor microenvironment. This radiotracer is the subject of a major development program in the field of oncology and hematologic malignancies. In many cancers, preliminary data suggest, in terms of diagnostic performance, the superiority of [68Ga] Ga-FAPI over the reference evaluation modality carried out with [18F] F-FDG. These results make it possible to consider, in the medium term, the integration of this imaging modality into routine care, for the initial evaluation and monitoring of certain tumor pathologies.

If oncology and hematology constitute the most obvious areas of application of [68Ga] Ga-FAPI, other areas of potential use were quickly mentioned, due to the involvement of activated fibroblasts in the processes. remodeling of the extracellular matrix and tissue repair in general, beyond tumor pathologies. Non-exhaustively, the potential interest of the radiotracer is thus suggested in the characterization of benign tumor pathologies, in the evaluation of ischemic tissues, in chronic inflammatory diseases and in fibrosing diseases. Numerous preliminary data show that it is relevant to develop knowledge concerning the contribution of [68Ga] Ga-FAPI to the evaluation of numerous benign pathologies.

It is in this general context that this single-center pilot study project falls, the general objective of which is to determine the preliminary interest of this imaging modality in different chronic inflammatory and/or fibrosing diseases. The pathologies included in this project were selected by taking into account the concomitant presence of unmet medical needs in terms of disease assessment and recognized local clinical research expertise in the area concerned. On these bases, 15 distinct clinical situations were selected, intended to enable the production of pilot data. This approach will be able to determine the interest in continuing clinical development in each area and will help to specify the modalities.

The 13 clinical situations selected for this pilot study are:

• Rheumatoid arthritis
• Spondyloarthritis
• Inflammatory enterocolopathies
• Liver fibrosis
• Fibrosing interstitial lung disease
• Systemic sarcoidosis
• Polymyalgia rheumatica and giant cell arteritis
• Primary Sjögren's syndrome
• Systemic scleroderma
• Systemic lupus
• Inflammatory myopathies
• Primary or secondary myelofibrosis
• Other orphan systemic diseases
• Endometriosis
• Chronic thrombo embolic disease

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre-Yves LE ROUX, PHD; Phone Number: +33 (0) 229020266; Email: pierre-yves.leroux@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHU Brest
    • Contact: Pierre-Yves LE ROUX, PU-PH; Phone Number: +33229020266; Email: pierre-yves.leroux@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ga68-FAPI46 TEP scan; In addition to the usual routine care, the study adds the performance of a [68Ga] Ga-FAPI PET/CT scan	Diagnostic test: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET uptake intensity	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.	Month 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation	- Measurement of PET fixation intensity	Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation	- Measurement of the pathology-specific reference score (if applicable)	Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation	- Measurement of PET fixation intensity	Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation	- Measurement of the pathology-specific reference score (if applicable)	Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation	- Measurement of PET fixation intensity	Month 6
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation	- Measurement of the pathology-specific reference score (if applicable)	Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation	- Measurement of PET uptake intensity	Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation	- Measurement of other pathology-specific assessment scores (if applicable)	Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation	- Measurement of PET uptake intensity	Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation	- Measurement of other pathology-specific assessment scores (if applicable)	Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation	- Measurement of PET uptake intensity	Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation	- Measurement of other pathology-specific assessment scores (if applicable)	Month 6
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation	- Measurement of PET fixation intensity	Month 0
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation	- Measurement of pathology-specific biological markers (if applicable). Biomarkers are specific to the pathologies studied (may include: CRP, Hb, Albumin, CRP, fecal calprotectin, IgG, native anti-DNA, proteinuria, CPK, ECA...).	Month 0
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation	- Measurement of PET fixation intensity	Month 3
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation	- Measurement of pathology-specific biological markers (if applicable). - Measurement of pathology-specific biological markers (if applicable). Biomarkers are specific to the pathologies studied (may include: CRP, Hb, Albumin, CRP, fecal calprotectin, IgG, native anti-DNA, proteinuria, CPK, ECA...).	Month 3
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation	- Measurement of PET fixation intensity	Month 6
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation	- Measurement of pathology-specific biological markers. - Measurement of pathology-specific biological markers (if applicable). Biomarkers are specific to the pathologies studied (may include: CRP, Hb, Albumin, CRP, fecal calprotectin, IgG, native anti-DNA, proteinuria, CPK, ECA...).	Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation	- Measurement of PET fixation intensity	Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation	- Measurement of pathology-specific functional parameters.	Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation	- Measurement of PET fixation intensity	Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation	- Measurement of pathology-specific functional parameters	Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation	- Measurement of PET fixation intensity	Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation	- Measurement of pathology-specific functional parameters.	Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation	- Measurement of PET uptake intensity	Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation	- Measurement of pathology-specific imaging characteristics.	Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation	- Measurement of PET uptake intensity	Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation	- Measurement of pathology-specific imaging characteristics.	Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation	- Measurement of PET uptake intensity	Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation	- Measurement of pathology-specific imaging characteristics.	Month 6
[68Ga] Ga-FAPI PET/CT parameters evolution	Describe the evolution of [68Ga] Ga-FAPI PET/CT parameters between M0 and M3 (Ki mean, Ki max (ml/min/100ml))	Month 0
[68Ga] Ga-FAPI PET/CT parameters evolution	Describe the evolution of [68Ga] Ga-FAPI PET/CT parameters between M0 and M3 (Ki mean, Ki max (ml/min/100ml))	Month 3
[68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison	- Measurement of the fixation intensity in PET/CT with [68Ga] Ga-FAPI and measurement of the fixation intensity in PET/CT with [18F] F-FDG at M0	Month 0
[68Ga] Ga-FAPI PET/CT kinetic	• Evaluation of the kinetics of uptake of the tracer [68Ga] Ga-FAPI in PET according to the different pathologies and their phenotypic characteristics (Distribution Volume (DV) mean, DV max (%))	Month 0
[68Ga] Ga-FAPI PET/CT kinetic	• Evaluation of the kinetics of uptake of the tracer [68Ga] Ga-FAPI in PET according to the different pathologies and their phenotypic characteristics (Distribution Volume (DV) mean, DV max (%))	Month 3
[68Ga] Ga-FAPI PET/CT kinetic	• Evaluation of the kinetics of uptake of the tracer [68Ga] Ga-FAPI in PET according to the different pathologies and their phenotypic characteristics (Distribution Volume (DV) mean, DV max (%))	Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): September 21, 2027
• Study Completion (Estimated): September 21, 2027

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; FAPI-46
• Other Study ID Numbers: 29BRC23.0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No