68Ga-P16-093 PET/CT Imaging in the Salivary Gland
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Diagnostic performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological diagnosis confirmed by operation or biopsy.
- •Obtain written informed consent and accepted follow-up.
排除标准
- •Pregnant, lactating women or having parenting plans during the study
- •Head and neck radiotherapy history ;
- •Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases.
- •Other situaition researchers considered it was not appropriate to participate in trials.
研究组 & 干预措施
68Ga-P16-093
Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093.
干预措施: 68Ga-P16-093 (Drug)
结局指标
主要结局
Diagnostic performance
时间窗: through study completion, an average of 1 year
evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093
次要结局
- standardized uptake value (SUV) of lesion(through study completion, an average of 1 year])