Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of VERDICT MRI
研究概览
简要总结
Multiparametric magnetic resonance imaging (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively before men undergo biopsy. Before these techniques are translated clinically, robust histological and clinical validation is required.
This study aims to clinically validate advanced MRI techniques in a cohort of men suspected with prostate cancer. Histological analysis of men undergoing biopsy, +/- prostatectomy will be used for biological validation of VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging (LWI). In particular, prostatectomy specimens will be processed using 3-D printed patient-specific moulds to allow for accurate MRI and histology mapping.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18-90 with a clinical suspicion of prostate cancer
- •No contraindication to MRI
- •Exclusion Criteria
- •Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
- •Men unable to given informed consent
- •Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
- •Ongoing hormonal treatment for prostate cancer
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of VERDICT MRI
时间窗: 2 years
Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone
Diagnostic accuracy of Luminal Water Imaging (LWI)
时间窗: 2 years
Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone
次要结局
- The proportions of true positives with index tests is the same as mpMRI.(2 years)
