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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-FAPI | Experimental | Inject 68Ga-FAPI and then perform PET/CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| 68Ga-FAPI and disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Liu, MD | Contact | 86 0592-2137749 | liuyuan@xmu.edu.cn | |
| Haojun Chen, PhD | Contact | 86 0592-2137166 | leochen0821@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guixiu Shi, PhD | The First Affiliated Hospital of Xiamen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D009220 | Myositis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000707753 | 68Ga-FAPI |
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|
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 | To evaluate whether the change of 68Ga-FAPI uptake in diseased tissue can be associated with disease activity after therapy. | Up to 2 years |