Safety and Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Prostate Cancer Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standardized uptake value of 68Ga-NOTA-RM26 in prostate cancer
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-RM26 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
详细描述
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including prostate cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human prostate cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-RM26 and to assess its clinical diagnostic value in patients with prostate cancer.
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
- 是
入选标准
- •Patients with diagnosis of primary prostate cancer having a prostate neoplasm identified by ultrasound or MRI, being diagnosed by needle biopsy as having prostate cancer, having undergone whole-body bone scanning, and being able to provide basic information and sign the written informed consent form.
排除标准
- •The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
研究组 & 干预措施
68Ga-NOTA-RM26 PET/CT
The patients were injected with 111-148 MBq of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 15-30 min later.
干预措施: 68Ga-NOTA-RM26 (Drug)
结局指标
主要结局
Standardized uptake value of 68Ga-NOTA-RM26 in prostate cancer
时间窗: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in prostate cancer will be measured.
次要结局
- Adverse events collection(1 week)