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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
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To evaluate the potential usefulness of 68Ga/18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various FAP-related disease patients.
Subjects with various FAP-related disease patients underwent 68Ga/18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-FAPI PET/CT were calculated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Group Assignment | Diagnostic Test | 68Ga-DOTA/NOTA-FAPI-04 Each subject receive a single intravenous injection of 68Ga/18F-FAPI, and undergo PET/CT imaging within the specificed time. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value (SUV) | Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficacy | The sensitivity, specificity and accuracy of FAPI PET/CT were calculated. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled FAPI PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haonan Yu, MD | Contact | +8613821000597 | dreamadam@126.com | |
| Shaobo Yao, PhD | Contact | +8615122570279 | yaoshaobo008@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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