Prostate Diffusion Imaging With Distortion Correction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- MRI image quality
研究概览
简要总结
There has been literature demonstrating the effectiveness of correcting these MRI images by using an additional measurement of the magnetic field, but the implied improvement in lesion detection in these common distorted regions in the prostate has yet to be shown.
We propose that introducing this distortion correction would greatly improve the DWI images used for tumour detection. For this study we propose testing this hypothesis as a primary objective, and as a secondary objective including additional b-values to further refine the ADC value. The study involves adding one additional distortion correcting scan to the standard clinical study, adding approximately 2 minutes to the study.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 诊断
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- Male
- Aged 18 and over
- No contraindication to MR scanning
- Smokers and non-smokers
- Patients who have had a complete scan on the 3T scan MRI at Norfolk and Norwich University Hospital and have gone on to have a biopsy at the Norfolk and Norwich University Hospital
排除标准
- Previous diagnosis of prostate cancer, prostatic biopsy or treatment for prostate cancer
研究组 & 干预措施
Imaging
干预措施: MRI scan (Diagnostic Test)
结局指标
主要结局
MRI image quality
时间窗: 12 months
To determine whether correcting for the distortion in MRI images caused by rectal gas improves the image quality and thus diagnostic ability in localising and detecting prostate cancer
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06185478
- 其他研究编号
- 250301 (15-02-19)
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (3个月后)
- 研究完成日期
- (3个月后)
- 最近核实
- (4个月前)
- 最近更新
- (3个月前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否