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To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [18F]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.
[18F]F-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [68Ga]Ga-PSMA-11 PET/CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET/ CT scan | Experimental | Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]F-PSMA-N5 | Drug | Each subject receive a single intravenous injection of [18F]F-PSMA-N5, and undergo PET/CT imaging within the specificed time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard uptake value(SUV) | Standard uptake value(SUV) of [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 for each target lesion of subjects. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficacy | The sensitivity, specificity and accuracy of [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET/CT were calculated. | 30 days |
| Number of lesions | The number of lesions detected by [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET/CT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Xie, MD | Contact | +8613721108043 | xieqiang1980@ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Xie | The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China University of Science and Technology(Anhui Provincial Hospital) | Recruiting | Hefei | Anhui | 230000 | 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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|
| [68Ga]Ga-PSMA-11 | Drug | Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time. |
|
|
| 30 days |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |