Robot-Assisted MRI-Guided Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the procedure has high false-negative rates. This represents a daily problem for urologists managing the disease, creates uncertainty and emotional stress for patients, and initiates a cascade of repeat testing and biopsies which also burden the investigators healthcare system.
The investigators believe that prostate biopsy can be improved by using a new biopsy paradigm. The investigators plan to perform MRI-guided prostate biopsies with robot-assistance for orienting a needle-guide through which the biopsy is taken. The combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity compared to regular TRUS biopsies.
The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety. The needle-guide robot is an investigational device developed in their Urology Robotics Laboratory.
详细描述
While prostate cancer is the most common non-dermatologic malignancy among men in the US, it is frequently indolent and may not require radical therapy, i.e. radical prostatectomy or external beam radiotherapy. There has been increased interest in conservative approaches to low risk disease, including both active surveillance and focal therapy. Both of these approaches require accurate mapping of the prostate to allow for reproducible access to diseased portions of the gland, for biopsy or treatment purposes. Magnetic resonance imaging (MRI) has been increasingly utilized for prostate cancer staging and is considered the most accurate technique available for imaging prostate cancer. Furthermore there is increasing concern about the use of freehand transrectal ultrasound (TRUS) and needle biopsying in terms of reproducibility and accuracy in mapping disease. With systematic TRUS-guided biopsy the sensitivity of the test is low (33%-44%) and yields high false-negative rates (23%) [1, 2].
The investigators hypothesize that the integration of a novel robotic device for assisting MRI-guided prostate biopsy is feasible, safe, and accurate. This represents the first clinical trial of robotic assistance for MRI-guided transperineal prostate biopsy. The device consists of a robotic needle-guide instrument developed in the investigators Urology Robotics Laboratory. The robot orients a needle-guide on target based on MRI. The physician verifies the alignment and manually takes the biopsy, as usual. Pre-clinical tests showed that the robot operates precisely and safely in the MRI scanner and does not deteriorate imaging quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men between the ages of 35 and 75,
- •have a negative 12 core prostate biopsy, and
- •must have one of the following "high risk" features:
- •PSA >= 5.0 ng/ml and Prostate Volume <= 50cc,
- •PSA density >= 0.2ng/ml/cc,
- •Percent Free PSA <=10%,
- •PSA velocity > 0.5 ng/ml/year,
- •High Grade Prostate Intraepithelial Neoplasia on previous biopsy, or Atypia on previous biopsy.
排除标准
- •bleeding problems,
- •metal implants precluding MRI scanning,
- •previous rectal surgery, anal stenosis that precludes endorectal coil insertion,
- •patients who cannot tolerate anesthesia or in whom anesthesia is considered high-risk, and
- •patients who are unwilling or unable to sign informed consent.
研究组 & 干预措施
Robot-assisted prostate biopsy
干预措施: Robot-assisted prostate biopsy (Device)
结局指标
主要结局
Number of participants with adverse events
时间窗: Three months
Score for operation of the device
时间窗: 1 year
Score assigned by the engineers on a 1 to 5 scale
Overall grade of the device and procedure
时间窗: 1 year
Grade give by urologist, radiologist and anesthesiologist on a 1-5 scale.
Logged unsuccessful attempts to target prostate
时间窗: 1 year
Time for device setup, image registration, MRI time, biopsy sampling
时间窗: 1 year
Score for image deterioration
时间窗: 1 year
Score assigned by radiologist on image quality on a 1 to 5 scale
Quality of the obtained biopsy specimen
时间窗: 1 year
Score assigned by the pathologist on a 1-5 scale.
次要结局
- Distance from the collected to planned biopsy core center measured on DICOM(One year)
- Number of diagnosed prostate cancers(1 year)
- Correlation of pathology findings with cancer specific region (CSR)s on MRI(1 year)
- Number of positive/total cores for each patient(1 year)
- Number of needle trajectory corrections needed for alignment of each biopsy core(1 year)