Inflammatory DiseasePARADISENCT06275477
68Gallium-FAPI46 PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases
A study testing 68Ga-FAPI46 in people with Inflammatory Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Disease
- What is being tested?
- 68Ga-FAPI46
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2025to 5 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29200
Pierre-Yves LE ROUX, PU-PH, +33229020266, pierre-yves.leroux@chu-brest.fr
About this study
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.
Read the 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
- Conditions
- Inflammatory Disease
- Being tested
- 68Ga-FAPI46
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI46Diagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Ga68-FAPI46 TEP scan | Experimental | In addition to the usual routine care, the study adds the performance of a [68Ga] Ga-FAPI PET/CT scan Receives: Diagnostic Test: 68Ga-FAPI46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 0
Secondary outcomes (36)
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
- Measurement of PET fixation intensity
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
- Measurement of the pathology-specific reference score (if applicable)
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
- Measurement of PET fixation intensity
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
- Measurement of the pathology-specific reference score (if applicable)
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
- Measurement of PET fixation intensity
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
- Measurement of the pathology-specific reference score (if applicable)
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
- Measurement of PET uptake intensity
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
- Measurement of other pathology-specific assessment scores (if applicable)
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
- Measurement of PET uptake intensity
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
- Measurement of other pathology-specific assessment scores (if applicable)
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
- Measurement of PET uptake intensity
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
- Measurement of other pathology-specific assessment scores (if applicable)
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
- Measurement of PET fixation intensity
Measured: 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...).
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
- Measurement of PET fixation intensity
Measured: 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...).
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
- Measurement of PET fixation intensity
Measured: 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...).
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
- Measurement of PET fixation intensity
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
- Measurement of pathology-specific functional parameters.
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
- Measurement of PET fixation intensity
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
- Measurement of pathology-specific functional parameters
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
- Measurement of PET fixation intensity
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
- Measurement of pathology-specific functional parameters.
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
- Measurement of PET uptake intensity
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
- Measurement of pathology-specific imaging characteristics.
Measured: Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
- Measurement of PET uptake intensity
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
- Measurement of pathology-specific imaging characteristics.
Measured: Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
- Measurement of PET uptake intensity
Measured: Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
- Measurement of pathology-specific imaging characteristics.
Measured: 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))
Measured: 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))
Measured: 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
Measured: 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 (%))
Measured: 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 (%))
Measured: 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 (%))
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start13 Mar 2025
- Primary completion5 Oct 2028 (estimated)
- Study completion5 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275477
- Sponsor's protocol ID
- 29BRC23.0029
- Acronym
- PARADISE
- Status last verified
- Jun 2026
- First submitted
- 29 Jan 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Gallium-FAPI46 PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases
- ClinicalTrials.gov ID
- NCT06275477
- Acronym / sponsor ID
- PARADISE / 29BRC23.0029
- Conditions
- Inflammatory Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 5 Oct 2028 (estimated)
- Study completion
- 5 Oct 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ga68-FAPI46 TEP scan | Experimental | Diagnostic Test: 68Ga-FAPI46In addition to the usual routine care, the study adds the performance of a [68Ga] Ga-FAPI PET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients unable to consent.
- Incapacitated adults.
- Pregnant or breastfeeding women.
- Patients refusing to participate in research.
- Known active cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI46Depending 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). | Diagnostic test | Ga68-FAPI46 TEP scan |
Primary outcome
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.
36 secondary outcomes
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Biomarkers correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Functional parameters correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time frame: Month 0
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time frame: Month 3
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time frame: Month 6
[68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation
Time frame: Month 6
[68Ga] Ga-FAPI PET/CT parameters evolution
Time frame: Month 0
[68Ga] Ga-FAPI PET/CT parameters evolution
Time frame: Month 3
[68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison
Time frame: Month 0
[68Ga] Ga-FAPI PET/CT kinetic
Time frame: Month 0
[68Ga] Ga-FAPI PET/CT kinetic
Time frame: Month 3
[68Ga] Ga-FAPI PET/CT kinetic
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI46 in people with Inflammatory Disease, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves LE ROUX, PHD (+33 (0) 229020266, pierre-yves.leroux@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET uptake intensity (time frame: Month 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.