Characterizing Myositis With 68Ga-FAPI PET/CT
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Haojun Chen, PhD
- Phone Number: 86 0592-2137166
- Email: leochen0821@foxmail.com
Study Contact Backup
- Name: Yuan Liu, MD
- Phone Number: 86 0592-2137749
- Email: liuyuan@xmu.edu.cn
Study Locations
-
-
Fujian
-
Xiamen, Fujian, China, 361000
- Recruiting
- The First Affiliated Hospital of Xiamen University
-
Principal Investigator:
- Yuan Liu, MD
-
Contact:
- Qiuwan Wu, PhD
- Phone Number: 86 0592-2137507
-
Principal Investigator:
- Haojun Chen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A diagnosis of myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
- Adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (ICF).
- 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.
- 68Ga-FAPI and 18F-FDG PET/CT were performed within two weeks.
Exclusion Criteria:
- Pregnancy;
- Breastfeeding;
- known allergy against FAPI;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 68Ga-FAPI
Inject 68Ga-FAPI and then perform PET/CT scan
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To define the distribution pattern of 68Ga-FAPI in patients with IIM
Time Frame: 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)).
|
60 minutes following injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity
Time Frame: 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.
|
30 days
|
|
68Ga-FAPI and disease progression
Time Frame: Up to 2 years
|
To evaluate whether the 68Ga-FAPI biodistribution in the diseased tissues can be associated with disease progression under therapies.
|
Up to 2 years
|
|
Therapy response
Time Frame: Up to 2 years
|
To evaluate whether the change of 68Ga-FAPI uptake in diseased tissue can be associated with disease activity after therapy.
|
Up to 2 years
|
Collaborators and Investigators
Investigators
- Study Director: Guixiu Shi, PhD, The First Affiliated Hospital of Xiamen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAPI in IIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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