NCT07615101招募中3 期
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.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 365
- 试验地点
- 2
研究概览
简要总结
The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.
详细描述
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Prostate-specific membrane antigen (PSMA) is a transmembrane surface protein highly overexpressed in over 90% of prostate cancer lesions.⁶⁸Ga-NYM032 Injection, a PSMA-targeted radiotracer, is indicated for PET/CT imaging in patients with prostate cancer. Patients will receive 68Ga-NYM032 imaging to identify pelvic lymph node involvement.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
68-Ga-NYM032
Experimental
干预措施: 68-Ga-NYM032 (Drug)
研究者
研究点 (2)
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