Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- Cancer upgrading during Active surveillance by micro-ultrasound and MRI
研究概览
简要总结
This study will compare the two imaging modalities (MRI and micro-ultrasound) during Active Surveillance of prostate cancer (PCa). Progression to clinically significant PCa will be assessed by first taking micro-US targeted samples (while blinded to MRI results), followed by MRI targeted samples, finishing with 12 systematic biopsy cores. The primary goal is to compare microUS to MRI for the detection of ≥GG2 PCa at confirmatory biopsy. This study will also collect blood samples from participants to be used for future biomarker studies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy
排除标准
- •Men who cannot undergo a prostate MRI
- •Men who cannot undergo a prostate biopsy
研究组 & 干预措施
Combined MRI and micro-ultrasound guided prostate biopsy.
In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.
干预措施: High-resolution micro-ultrasound (Device)
结局指标
主要结局
Cancer upgrading during Active surveillance by micro-ultrasound and MRI
时间窗: Immediately after biopsy.
The primary outcome will be detection of ≥Grade Group 2 by each biopsy, technique in combination with the systematic biopsy.
次要结局
- Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.(Immediately after biopsy.)