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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
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To evaluate the potential usefulness of 68Ga/18F-PSMA/PSFA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various PSMA-related disease patients.
Subjects with various PSMA-related disease patients underwent 68Ga/18F-PSMA/PSFA 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-PSMA/PSFA PET/CT were calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group Assignment | Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga/18F-PSMA/PSFA | Diagnostic Test | Each subject receive a single intravenous injection of 68Ga/18F-PSMA/PSFA, and undergo PET/CT imaging within the specificed time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value (SUV) | Standardized uptake value (SUV) of PSMA 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 PSMA PET/CT were calculated. | 30 days |
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Inclusion Criteria:
- (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 PSMA 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.
Exclusion Criteria:
- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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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 PSMA 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | Anhui | 230000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41120594 | Derived | Wang X, Wang M, Chen Y, Jian R, Yu H, Zhang X, Zhang J, Yao S, Du J, Cui M. Preclinical evaluation and first-in-human study of 68Ga- and Al18F-Labeled PSMA/FAP bispecific tracers for prostate cancer imaging. Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2489-2501. doi: 10.1007/s00259-025-07591-7. Epub 2025 Oct 22. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |