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Characterizing Myositis With 68Ga-FAPI PET/CT

Primary Purpose

Myositis, Idiopathic Inflammatory Myopathies

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI
Sponsored by
The First Affiliated Hospital of Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myositis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The first affiliated hospital of Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-FAPI

Arm Description

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

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

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.
68Ga-FAPI and disease progression
To evaluate whether the 68Ga-FAPI biodistribution in the diseased tissues can be associated with disease progression under therapies.
Therapy response
To evaluate whether the change of 68Ga-FAPI uptake in diseased tissue can be associated with disease activity after therapy.

Full Information

First Posted
July 12, 2023
Last Updated
July 12, 2023
Sponsor
The First Affiliated Hospital of Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT05952531
Brief Title
Characterizing Myositis With 68Ga-FAPI PET/CT
Official Title
Characterizing Myositis With 68Ga-FAPI PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myositis, Idiopathic Inflammatory Myopathies

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-FAPI
Arm Type
Experimental
Arm Description
Inject 68Ga-FAPI and then perform PET/CT scan
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI
Other Intervention Name(s)
68Ga-fibroblast activating protein inhibitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
To define the distribution pattern of 68Ga-FAPI in patients with IIM
Description
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)).
Time Frame
60 minutes following injection
Secondary Outcome Measure Information:
Title
Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity
Description
The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity.
Time Frame
30 days
Title
68Ga-FAPI and disease progression
Description
To evaluate whether the 68Ga-FAPI biodistribution in the diseased tissues can be associated with disease progression under therapies.
Time Frame
Up to 2 years
Title
Therapy response
Description
To evaluate whether the change of 68Ga-FAPI uptake in diseased tissue can be associated with disease activity after therapy.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Liu, MD
Phone
86 0592-2137749
Email
liuyuan@xmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Haojun Chen, PhD
Phone
86 0592-2137166
Email
leochen0821@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guixiu Shi, PhD
Organizational Affiliation
The First Affiliated Hospital of Xiamen University
Official's Role
Study Director
Facility Information:
Facility Name
The first affiliated hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuwan Wu, PhD
Phone
86 0592-2137507
First Name & Middle Initial & Last Name & Degree
Yuan Liu, MD
First Name & Middle Initial & Last Name & Degree
Haojun Chen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Characterizing Myositis With 68Ga-FAPI PET/CT

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