Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of times the first biopsy needle is placed within 3.0 mm of the center lesion
研究概览
简要总结
This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer
详细描述
PRIMARY OBJECTIVES:
I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.
OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) >= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
- •Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
- •Subjects must have decided to have their prostate surgically removed
排除标准
- •Patients who do not give informed consent
- •Patients with extracapsular extension of their prostate cancer
结局指标
主要结局
Number of times the first biopsy needle is placed within 3.0 mm of the center lesion
时间窗: One month after last patient enrolled is taken off study
A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).
Number of times the second biopsy needle is placed within 3.0 mm of the center lesion
时间窗: One month after last patient enrolled is take off study
A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).
次要结局
- Average distance of the second needle from the first needle minus 2.0 mm(One month after last patient enrolled is taken off study)
- Average distance of the third needle from the first needle minus 2.0 mm(One month after last patient enrolled is taken off study)
- Average distance of the first needle to the center of the lesion(One month after last patient enrolled is taken off study)