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

June 15, 2026 updated by: University Hospital, Brest
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Month 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time Frame: Month 0
- Measurement of PET fixation intensity
Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time Frame: Month 0
- Measurement of the pathology-specific reference score (if applicable)
Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time Frame: Month 3
- Measurement of PET fixation intensity
Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time Frame: Month 3
- Measurement of the pathology-specific reference score (if applicable)
Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time Frame: Month 6
- Measurement of PET fixation intensity
Month 6
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time Frame: Month 6
- Measurement of the pathology-specific reference score (if applicable)
Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time Frame: Month 0
- Measurement of PET uptake intensity
Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time Frame: Month 0
- Measurement of other pathology-specific assessment scores (if applicable)
Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time Frame: Month 3
- Measurement of PET uptake intensity
Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time Frame: Month 3
- Measurement of other pathology-specific assessment scores (if applicable)
Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time Frame: Month 6
- Measurement of PET uptake intensity
Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time Frame: Month 6
- Measurement of other pathology-specific assessment scores (if applicable)
Month 6
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time Frame: Month 0
- Measurement of PET fixation intensity
Month 0
[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...).
Month 0
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time Frame: Month 3
- Measurement of PET fixation intensity
Month 3
[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...).
Month 3
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time Frame: Month 6
- Measurement of PET fixation intensity
Month 6
[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...).
Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time Frame: Month 0
- Measurement of PET fixation intensity
Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time Frame: Month 0
- Measurement of pathology-specific functional parameters.
Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time Frame: Month 3
- Measurement of PET fixation intensity
Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time Frame: Month 3
- Measurement of pathology-specific functional parameters
Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time Frame: Month 6
- Measurement of PET fixation intensity
Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time Frame: Month 6
- Measurement of pathology-specific functional parameters.
Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time Frame: Month 0
- Measurement of PET uptake intensity
Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time Frame: Month 0
- Measurement of pathology-specific imaging characteristics.
Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time Frame: Month 3
- Measurement of PET uptake intensity
Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time Frame: Month 3
- Measurement of pathology-specific imaging characteristics.
Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time Frame: Month 6
- Measurement of PET uptake intensity
Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time Frame: Month 6
- Measurement of pathology-specific imaging characteristics.
Month 6
[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))
Month 0
[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))
Month 3
[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
Month 0
[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 (%))
Month 0
[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 (%))
Month 3
[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 (%))
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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