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The purpose of this study is to evaluate the safety of fibroblast activating protein receptor imaging agent [68Ga]/ Fluorine [18F] -fibroblast activating protein inhibitor (68Ga/18F-FAPI-04) in clinical application and to verify its effectiveness in the diagnosis of cardiovascular diseases.
The implementation of this project will promote the research of PET-MRI molecular imaging using the new nuclide imaging with the target of FAP combined with the MRI T1 mapping and ECV measurement technology, realize the fusion of nuclear medicine and magnetic resonance technology in a real sense, dynamically monitor the occurrence and development of myocardial fibrosis in heart failure at an early stage, and establish a complete set of myocardial fibrosis imaging programs. To provide an important basis for the exploration of anti-fibrosis therapy in heart failure and accelerate the pace of clinical transformation of this protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga/18F-FAPI-04 | Experimental | For the injection, subjects will receive a target dose of 0.1~0.15mCi/Kg 68Ga/18F-FAPI-04 as a bolus injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga/18F-FAPI-04 | Drug | Subjects will receive one injection of 68Ga/18F-FAPI-04 (0.1~0.15mCi/Kg), a PET radiopharmaceutical selective for fibroblast activation protein. 68Ga/18F-FAPI-04 injection will be followed by a 10 ml saline flush. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of 68Ga/18F-FAPI-04 Uptake Patterns by Regional SUV Values | 68Ga/18F-FAPI-04 uptake patterns will be assessed in regions of interest (ROIs) which relevant to myocardial fibrosis pathology. Standard uptake value (SUV) will be calculated for each ROI, and standardized uptake value ratios (SUVRs) will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region. | 31 months |
| Safety and Tolerability Profile Measured by Adverse Events (AEs) | Safety and tolerability profile for the administration of 68Ga/18F-FAPI-04 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs). | 31 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wang | Contact | 02552271491 | fengwangcn@hotmail.com | |
| Rui Luo | Contact | 02552271491 | luorui0916@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Wang | Nanjing First Hospital, Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40690085 | Derived | Luo R, Zhao Z, Zhang C, Li RS, Wang Y, Meng Q, Ni Y, Wang B, Li L, Feng L, Yang R, Xie L, Chen X, Zhang MR, Wang F. Evaluation of myocardial fibrosis and wall motion abnormality with 68Ga-FAPI PET/MR in coronary heart disease. EJNMMI Res. 2025 Jul 21;15(1):89. doi: 10.1186/s13550-025-01246-2. |
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