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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 69
- 主要终点
- Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.
研究概览
简要总结
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.
详细描述
This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged 21 years or older.
- •Ability to provide signed informed consent and willingness to comply with protocol requirements.
- •Biopsy confirmed presence of adenocarcinoma of the prostate gland.
- •At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to
- •Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
- •Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection.
排除标准
- •Participating would significantly delay the scheduled standard of care therapy.
- •Administered a radioisotope within 5 physical half lives prior to study drug injection.
- •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.
- •Have a contraindication for MR imaging.
结局指标
主要结局
Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.
时间窗: Within 3-6 hours of dosing SPECT/CT images will be taken
For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.
次要结局
- Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes(Within 3-6 hours of dosing SPECT/CT images will be taken)
- Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.(Within 3-6 hours of dosing SPECT/CT images will be taken)
- Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland(Within 3-6 hours of dosing SPECT/CT images will be taken)
- Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions(Within 3-6 hours of dosing SPECT/CT images will be taken)
- Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.(Within 3-6 hours of dosing SPECT/CT images will be taken)