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| Name | Class |
|---|---|
| SOFIE INC | UNKNOWN |
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The aim of this study is to compare the diagnostic performance of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in primary and metastatic lesions of breast cancer and to reveal the best diagnostic imaging time of 68Ga-FAPI-46 PET/CT.
Participants with breast carcinoma will undergo contemporaneous 18F-FDG and 68Ga-FAPI PET/CT. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT will be calculated and compared to evaluate the diagnostic efficacy. In addition, best diagnostic imaging time of 68Ga-FAPI-46 PET/CT will be evaluated at 10th, 30th and 60th minute scan time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-FAPI-46 PET/CT + 18-FDG PET/CT | Experimental | 18FDG PET/CT scan is followed by [68Ga]FAPI-46 PET/CT within 2-3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI-46 PET/CT | Diagnostic Test | Patients are scanned 10 minute, 30 minute and 1 hour after 68Ga-FAPI-46 as well as one hour 18-FDG injection within 2-3 days interval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum standardised uptake value [SUVmax] for primary lesion | SUVmax of 68Ga-FAPI PET/CT for breast carcinoma in comparison with SUVmax value of 18F-FDG PET/CT | 2-3 days |
| Best diagnostic imaging time of 68GaFAPI-46 PET/CT | Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time | 2-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficacy for breast carcinomas | Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for breast carcinomas in comparison with 18F-FDG PET/CT | 2 days |
| SUVmax for metastatic lymph nodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuad Novruzov, MD PhD | Contact | +994 50 335 09 44 | drnovruzov@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Centre of Oncology | Recruiting | Baku | AZ1011 | Azerbaijan |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT |
| 2 days |
| Diagnostic efficacy for metastatic lymph nodes | Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT | 2 days |
| Correlation between tumor SUVmax values and pathology grade | Correlation between tumor SUVmax values and pathology grade calculated | 2 days |
| D017437 |
| Skin and Connective Tissue Diseases |