Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Jiangsu
-
Nanjing、Jiangsu、中国
- 招聘中
- Affiliated Drum Tower Hospital, Medical School of Nanjing University
-
接触：
- Hongqian Guo, MD
- 电话号码：13605171690
- 邮箱：gymwpi@126.com
-
Wuxi、Jiangsu、中国
- 招聘中
- Affiliated Hospital of Jiangnan University
-
接触：
- Chunjing Yu, MD
- 电话号码：15312238622
- 邮箱：ycj_wxd1978@163.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patient is male and aged >18 years old.
- Biopsy proven prostate adenocarcinoma.
- Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
- ECOG performance status 0-2; expected survival ≥ 6 months.
6. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
1. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.
2. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
3. Known hypersensitivity to the active ingredient or excipients of the study drug.
4. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
5. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：68-Ga-NYM032
|
IV injection
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
sensitivity and specificity
大体时间：up to 30 days
|
Assessing the sensitivity and specificity of 68Ga-NYM032 Injection positron emission tomography (PET) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
|
up to 30 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.