Trials / Unknown
UnknownNCT05952531
Characterizing Myositis With 68Ga-FAPI PET/CT
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- The First Affiliated Hospital of Xiamen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2024-07-01
- Completion
- 2025-07-01
- First posted
- 2023-07-19
- Last updated
- 2023-07-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05952531. Inclusion in this directory is not an endorsement.