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NCT Number: NCT06275477

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

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.

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Key information

Conditions

Inflammatory Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

[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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

68Ga-FAPI46

Diagnostic Test

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).

Primary outcomes

  1. PET uptake intensity

    Time frame: 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.

Secondary outcomes

  1. [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation

    Time frame: Month 0

    • Measurement of PET fixation intensity

  2. [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation

    Time frame: Month 0

    • Measurement of the pathology-specific reference score (if applicable)

  3. [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation

    Time frame: Month 3

    • Measurement of PET fixation intensity

  4. [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation

    Time frame: Month 3

    • Measurement of the pathology-specific reference score (if applicable)

  5. [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation

    Time frame: Month 6

    • Measurement of PET fixation intensity

  6. [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation

    Time frame: Month 6

    • Measurement of the pathology-specific reference score (if applicable)

  7. [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation

    Time frame: Month 0

    • Measurement of PET uptake intensity

  8. [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation

    Time frame: Month 0

    • Measurement of other pathology-specific assessment scores (if applicable)

  9. [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation

    Time frame: Month 3

    • Measurement of PET uptake intensity

  10. [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation

    Time frame: Month 3

    • Measurement of other pathology-specific assessment scores (if applicable)

  11. [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation

    Time frame: Month 6

    • Measurement of PET uptake intensity

  12. [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation

    Time frame: Month 6

    • Measurement of other pathology-specific assessment scores (if applicable)

  13. [68Ga]Ga-FAPI PET/CT - Biomarkers correlation

    Time frame: Month 0

    • Measurement of PET fixation intensity

  14. [68Ga]Ga-FAPI PET/CT - Biomarkers correlation

    Time frame: Month 0

    • 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...).

  15. [68Ga]Ga-FAPI PET/CT - Biomarkers correlation

    Time frame: Month 3

    • Measurement of PET fixation intensity

  16. [68Ga]Ga-FAPI PET/CT - Biomarkers correlation

    Time frame: Month 3

    • 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...).

  17. [68Ga]Ga-FAPI PET/CT - Biomarkers correlation

    Time frame: Month 6

    • Measurement of PET fixation intensity

  18. [68Ga]Ga-FAPI PET/CT - Biomarkers correlation

    Time frame: Month 6

    • 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...).

  19. [68Ga]Ga-FAPI PET/CT - Functional parameters correlation

    Time frame: Month 0

    • Measurement of PET fixation intensity

  20. [68Ga]Ga-FAPI PET/CT - Functional parameters correlation

    Time frame: Month 0

    • Measurement of pathology-specific functional parameters.

  21. [68Ga]Ga-FAPI PET/CT - Functional parameters correlation

    Time frame: Month 3

    • Measurement of PET fixation intensity

  22. [68Ga]Ga-FAPI PET/CT - Functional parameters correlation

    Time frame: Month 3

    • Measurement of pathology-specific functional parameters

  23. [68Ga]Ga-FAPI PET/CT - Functional parameters correlation

    Time frame: Month 6

    • Measurement of PET fixation intensity

  24. [68Ga]Ga-FAPI PET/CT - Functional parameters correlation

    Time frame: Month 6

    • Measurement of pathology-specific functional parameters.

  25. [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation

    Time frame: Month 0

    • Measurement of PET uptake intensity

  26. [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation

    Time frame: Month 0

    • Measurement of pathology-specific imaging characteristics.

  27. [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation

    Time frame: Month 3

    • Measurement of PET uptake intensity

  28. [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation

    Time frame: Month 3

    • Measurement of pathology-specific imaging characteristics.

  29. [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation

    Time frame: Month 6

    • Measurement of PET uptake intensity

  30. [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation

    Time frame: Month 6

    • Measurement of pathology-specific imaging characteristics.

  31. [68Ga] Ga-FAPI PET/CT parameters evolution

    Time frame: Month 0

    Describe the evolution of [68Ga] Ga-FAPI PET/CT parameters between M0 and M3 (Ki mean, Ki max (ml/min/100ml))

  32. [68Ga] Ga-FAPI PET/CT parameters evolution

    Time frame: Month 3

    Describe the evolution of [68Ga] Ga-FAPI PET/CT parameters between M0 and M3 (Ki mean, Ki max (ml/min/100ml))

  33. [68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison

    Time frame: Month 0

    • 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

  34. [68Ga] Ga-FAPI PET/CT kinetic

    Time frame: Month 0

    • 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 (%))

  35. [68Ga] Ga-FAPI PET/CT kinetic

    Time frame: Month 3

    • 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 (%))

  36. [68Ga] Ga-FAPI PET/CT kinetic

    Time frame: Month 6

    • 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 (%))

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre-Yves LE ROUX, PHD

CONTACT

[email protected]

+33 (0) 229020266

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PARADISE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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