Characterizing Myositis With 68Ga-FAPI PET/CT
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJuly 19, 2023
July 1, 2023
1 year
July 12, 2023
July 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity
30 days
68Ga-FAPI and disease progression
Up to 2 years
Therapy response
Up to 2 years
Study Arms (1)
68Ga-FAPI
EXPERIMENTALInject 68Ga-FAPI and then perform PET/CT scan
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- Ga-FAPI and 18F-FDG PET/CT were performed within two weeks.
You may not qualify if:
- Pregnancy;
- Breastfeeding;
- known allergy against FAPI;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first affiliated hospital of Xiamen University
Xiamen, Fujian, 361000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guixiu Shi, PhD
The First Affiliated Hospital of Xiamen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2023
First Posted
July 19, 2023
Study Start
July 1, 2023
Primary Completion
July 1, 2024
Study Completion
July 1, 2025
Last Updated
July 19, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share