NCT06275477

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Mar 2025Sep 2027

First Submitted

Initial submission to the registry

January 29, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 13, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

January 29, 2024

Last Update Submit

March 3, 2026

Conditions

Inflammatory Disease

Outcome Measures

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.

    Month 0

Secondary Outcomes (36)

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

    Month 0

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

    Month 0

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

    Month 3

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

    Month 3

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

    Month 6

  • +31 more secondary outcomes

Study Arms (1)

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

Diagnostic Test: 68Ga-FAPI46

Interventions

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).

Ga68-FAPI46 TEP scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29200, France

RECRUITING

Central Study Contacts

Pierre-Yves LE ROUX, PHD

CONTACT

+33 (0) 229020266pierre-yves.leroux@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 23, 2024

Study Start

March 13, 2025

Primary Completion (Estimated)

September 21, 2027

Study Completion (Estimated)

September 21, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

FR(1)