SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Cancer Detection
研究概览
简要总结
The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.
The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.
An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.
SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.
This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget
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
- •Previous TRUS biopsy with clinical indication for repeat biopsy
- •Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale
- •An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
- •Signed informed consent
排除标准
- •Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
- •Men with an irreversible coagulopathy predisposing to bleeding
- •Men who are unability to undergo transrectal ultrasonography
- •Men who have had previous radiation therapy to the pelvis
- •Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
- •Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- •Men who are unable to give informed consent
研究组 & 干预措施
Biopsy
Single Arm Study. Biopsy Intervention.
干预措施: SmartTarget - Biopsy (Procedure)
结局指标
主要结局
Cancer Detection
时间窗: Within 3 weeks of biopsy
The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.
次要结局
- Targeting Efficiency (core length, grade)(Within 3 weeks of Biopsy)
- Quality of Life(6 Weeks post biopsy)
- Clinical Usability (length of procedure, generation time, re-registration rate, failure rate)(During Procedure)