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

ConditionInflammatory Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients unable to consent.

Incapacitated adults.

Pregnant or breastfeeding women.

Patients refusing to participate in research.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

390 Participants
are divided into 1 treatment group
Group A: Ga68-FAPI46 TEP scanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Month 0

Secondary outcomes

1

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

\- Measurement of PET fixation intensity

Time frame
Month 0
2

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

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

Time frame
Month 0
3

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

\- Measurement of PET fixation intensity

Time frame
Month 3
4

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

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

Time frame
Month 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Brest

Lead sponsor

Source ClinicalTrials.gov
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