Characterizing Myositis With 68Ga-FAPI PET/CT

Myositis Clinical Trial

Official title:

Characterizing Myositis With 68Ga-FAPI PET/CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952531
• Other study ID #: FAPI in IIM
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Yuan Liu, MD
• Phone: 86 0592-2137749
• Email: liuyuan[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Inflammatory Myopathies
• Myositis

Intervention

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.

Locations

Country	Name	City	State
China	The first affiliated hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the distribution pattern of 68Ga-FAPI in patients with IIM	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)).	60 minutes following injection
Secondary	Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity	The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity.	30 days
Secondary	68Ga-FAPI and disease progression	To evaluate whether the 68Ga-FAPI biodistribution in the diseased tissues can be associated with disease progression under therapies.	Up to 2 years
Secondary	Therapy response	To evaluate whether the change of 68Ga-FAPI uptake in diseased tissue can be associated with disease activity after therapy.	Up to 2 years