EUCTR2012-001864-30-NL进行中（未招募）不适用
A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Subjects must meet all of the following criteria to be enrolled in this study:
- •1. Male aged 21 years or older.
- •2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
- •3. Biopsy confirmed presence of adenocarcinoma of the prostate gland.
- •4. At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130
- •5. Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
- •6. Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc-MIP-1404 injection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Subjects must not meet any of the following criteria to be enrolled in this study:
- •1. Participating would significantly delay the scheduled standard of care therapy.
- •2. Administered a radioisotope within 5 physical half lives prior to study drug injection.
- •3. Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
- •4. Have a contraindication for MR imaging.
研究者
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