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| Name | Class |
|---|---|
| First Affiliated Hospital of Jinan University | OTHER |
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This goal of this study is to investigate the dosimetry, safety, biodistribution of ⁶⁸Ga-FC516. In this study, we will evaluate the safety, biodistribution and dosimetry of ⁶⁸Ga-FC516 in subjects and compared them with the results of ⁶⁸Ga-labeled prostate cancer-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ⁶⁸Ga-FC516 PET/CT | Experimental |
| |
| ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ⁶⁸Ga-FC516 | Drug | Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) and SAEs | Approximately 6 months | |
| Standard uptake value (SUV) of tumors | Compare the SUV of tumor between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT | Approximately 6 months |
| Human dosimetry | Radiation dose to individual organs and the equivalent dose for the whole body of each subject. | Approximately six months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor detection rate | Compare the tumor detection rate between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT. | Approximately six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingjin Wang | Contact | 18664044814 | wangtingjin@find-cure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Jinan University | Recruiting | Guangzhou | Guangdong | China |
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| ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer | Drug | Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two. |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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