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临床试验/NCT04792138
NCT04792138Unknown不适用

Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis

University College, London1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月23日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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