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To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 PET/CT either for an initial assessment or for recurrence detection. Tumor 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-DOTA/NOTA-FAPI-04 PET/CT were calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 68Ga-DOTA/NOTA-FAPI-04 | Experimental | Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTA/NOTA-FAPI-04 | Drug | Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value (SUV) | Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 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 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated. | 30 days |
| Diagnostic efficacy | The positive predictive value (PPV), negative predictive value (NPV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibing Miao, MD | Contact | 86-0591-87981618 | miaoweibing@126.com | |
| Shan Zheng, MD | Contact | 86-0591-87981619 | zhengshan1982@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36723892 | Derived | Zheng S, Lin J, Zhu Y, Chen Y, Zhang J, Chen X, Miao W. 68Ga-FAPI Versus 18F-FDG PET/CT in Evaluating Newly Diagnosed Breast Cancer Patients: A Head-to-Head Comparative Study. Clin Nucl Med. 2023 Mar 1;48(3):e104-e109. doi: 10.1097/RLU.0000000000004523. Epub 2023 Jan 10. | |
| 35551610 | Derived | Chen Y, Zheng S, Zhang J, Yao S, Miao W. 68Ga-DOTA-FAPI-04 PET/CT imaging in radioiodine-refractory differentiated thyroid cancer (RR-DTC) patients. Ann Nucl Med. 2022 Jul;36(7):610-622. doi: 10.1007/s12149-022-01742-8. Epub 2022 May 12. |
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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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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| PET/CT scan | Diagnostic Test | PET/CT scan |
|
| 30 days |
| 34424505 | Derived | Zheng S, Lin R, Chen S, Zheng J, Lin Z, Zhang Y, Xue Q, Chen Y, Zhang J, Lin K, You X, Yao S, Miao W. Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT. Ann Nucl Med. 2021 Dec;35(12):1312-1320. doi: 10.1007/s12149-021-01673-w. Epub 2021 Aug 23. |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |