Clinical Evidence Generation of AI Enabled Fast, Accurate and Precise Screening and Staging of Benign vs Malignant Pelvic Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in image quality (healthy volunteers)
研究概览
简要总结
This study evaluates whether newly developed non-FDA approved image processing techniques [Adaptive Image Reconstruction (AIR Recon) Deep Learning (DL) and Sonic DL] can provide improved quality and decreased time compared to current scanning techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient over the age of 18
- •For prostate group, any patient referred for prostate MR for screening purposes with no prior prostate related treatment or prior biopsy
- •For endometriosis group, any patient referred for possible endometriosis evaluation (pre-surgical)
排除标准
- •Individuals unable to undergo MRI imaging (MR-conditional or MR-nonconditional devices which would need additional procedures/conditions for scanning, pregnant people, individuals with implanted metal, etc.)
- •Patient under the age of 18
- •Patient who is unable to consent
研究组 & 干预措施
Observational
Participants undergo MRI on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Change in image quality (healthy volunteers)
时间窗: Baseline
Three expert radiologists will read scans (blinded to technique) and provide qualitative feedback to score image quality for standard of care (SOC) imaging, SOC with AirRecon DL, SOC with Sonic DL, and SOC with AirRecon DL and Sonic DL. Reader scoring will use a 1-5 Likert scale (1-5; 1:poor, 5:excellent).
Change in scan time
时间窗: Baseline
Will be considered improved if the duration of the added imaging does not exceed 10 minutes
次要结局
未报告次要终点