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Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.
Primary sjogren's syndrome (pSS) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary Sjogren's syndrome patients.Therefore, PSMA may be an ideal target for evaluating salivary gland injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-P16-093 | Experimental | Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-P16-093 | Drug | Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of glioma by PET/CT. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance | evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093 | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| standardized uptake value (SUV) of lesion | comparing the SUVmax of different grades in salivary gland lesion, derived from 68Ga-P16-093 | through study completion, an average of 1 year] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Zhu, MD | Contact | 86-13611093752 | 13611093752@163.com | |
| Jialin Xiang | Contact | 86-13051615100 | jialinx29@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Zhu, MD | Peking Union Medical College Hospital | Principal Investigator |
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