Evaluating 68Ga-FAPI PET/CT for diagnosing myositis
Characterizing Myositis With 68Ga-FAPI PET/CT
This study is testing a new type of imaging called 68Ga-FAPI PET/CT to see if it can better diagnose myositis and check for related issues compared to the current imaging method.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT05952531 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of 68Ga-FAPI PET/CT imaging in diagnosing and evaluating systemic involvement in idiopathic inflammatory myopathies (IIM), also known as myositis. It will compare the results of this new imaging technique with the established 18F-FDG PET/CT method. The study will focus on various aspects of myositis, including muscle and cardiac involvement, interstitial lung diseases, and potential underlying cancers. Participants will undergo both imaging procedures within a two-week timeframe to gather comprehensive data on the utility of 68Ga-FAPI PET/CT.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of myositis according to established criteria.
Not a fit: Patients who are pregnant, breastfeeding, or have known allergies to FAPI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnosis and better management of myositis and related conditions.
How similar studies have performed: Previous studies have shown that 68Ga-FAPI PET/CT may be more sensitive than traditional methods in detecting inflammation in related conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xiamen, Fujian
- The first affiliated hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Yuan Liu, MD
- Email: liuyuan@xmu.edu.cn
- Phone: 86 0592-2137749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.