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Characterizing Myositis With 68Ga-FAPI PET/CT

Sponsor
The First Affiliated Hospital of Xiamen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05952531
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis and evaluation of systemic involvement in idiopathic inflammatory myopathies (IIM)/myositis, and compared the results with those of 18F-FDG PET/CT.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Inflammatory myopathies (IIM), collectively known as myositis, are heterogeneous systemic autoimmune disorders characterized by muscle inflammation, and frequently accompanied by extra-muscular manifestations that affect the skin, lung, and joints. Prevalence of underlying malignancy is high in patients with IIM.

68Ga-FAPI has been developed as tracers specific for fibroblast-activation protein (FAP), which is overexpressed in activated fibroblasts in various type of cancers and autoimmune diseases, such as rheumatoid arthritis, IgG4-related diseases and interstitial lung diseases.

Recently the investigators have published articles of the application of 68Ga-FAPI in IgG4-related disease and rheumatoid arthritis, which showed it was more sensitive than FDG in detecting a certain type of inflammation, and the potential utility of FAP-targeted PET/CT imaging for disease assessment in myositis have been reported in a case recently.

Thus, this prospective study is going to investigate utility of 68Ga-FAPI PET/CT in diagnosis, disease assessment including skeletal muscle involvement, cardiac involvement, interstitial lung diseases and potential underlying cancer screening, response to treatment and prognosis, compared with 18F-FDG PET/CT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Characterizing Myositis With 68Ga-FAPI PET/CT
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-FAPI

Inject 68Ga-FAPI and then perform PET/CT scan

Drug: 68Ga-FAPI
Intravenous injection of one dosage of 111-185 MBq (3-5 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image IIM lesions in skeletal muscle, heart, lung, skin and potential tumor by PET/CT.
Other Names:
  • 68Ga-fibroblast activating protein inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To define the distribution pattern of 68Ga-FAPI in patients with IIM [60 minutes following injection]

      To quantify 68Ga-FAPI positron emission tomography (PET) tracer biodistribution in diseased tissue including muscle, heart, lung and normal background organs. 68Ga-FAPI positron emission tomography (PET) tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).

    Secondary Outcome Measures

    1. Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity [30 days]

      The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity.

    2. 68Ga-FAPI and disease progression [Up to 2 years]

      To evaluate whether the 68Ga-FAPI biodistribution in the diseased tissues can be associated with disease progression under therapies.

    3. Therapy response [Up to 2 years]

      To evaluate whether the change of 68Ga-FAPI uptake in diseased tissue can be associated with disease activity after therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. A diagnosis of myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria

    2. Adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (ICF).

    3. Participants who were able to provide informed consent (signed by participant or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

    4. 68Ga-FAPI and 18F-FDG PET/CT were performed within two weeks.

    Exclusion Criteria:

    1. Pregnancy;

    2. Breastfeeding;

    3. known allergy against FAPI;

    4. any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The first affiliated hospital of Xiamen University Xiamen Fujian China 361000

    Sponsors and Collaborators

    • The First Affiliated Hospital of Xiamen University

    Investigators

    • Study Director: Guixiu Shi, PhD, The First Affiliated Hospital of Xiamen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital of Xiamen University
    ClinicalTrials.gov Identifier:
    NCT05952531
    Other Study ID Numbers:
    • FAPI in IIM
    First Posted:
    Jul 19, 2023
    Last Update Posted:
    Jul 19, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myositis

    Study Results

    No Results Posted as of Jul 19, 2023