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To evaluate the potential usefulness of 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions, efficacy assessment and recurrence monitoring in various types of cancer.
Subjects with various types of cancer underwent 68Ga-PSMA-11 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-PSMA-11 PET/CT were calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-PSMA-11 | Experimental | Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-PSMA-11 | Drug | Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value (SUV) | Standardized uptake value (SUV) of 68Ga-PSMA-11 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-PSMA-11 PET/CT were calculated. | 30 days |
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Inclusion Criteria:
(i) adult population (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 68Ga-PSMA-11 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 pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibing Miao, MD | Contact | 86-0591-87981618 | miaoweibing@126.com | |
| Shaoming Chen, MD | Contact | 86-0591-87981619 | shaoming81@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |