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临床试验/NCT01766869
NCT01766869撤回不适用

Improving Cancer Foci Detection in Prostate Cancer Using Multiparametric MRI/MRS and Machine Learning to Better Manage the Disease

University of Maryland, Baltimore1 个研究点 分布在 1 个国家开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Primary Objective: distinguishing high-grade tumors vs. low-grade tumors and normal prostate

研究概览

简要总结

The investigators' goal is to develop a non-selective and non-invasive procedure to identify aggressive tumors and simultaneously identify their exact location in Prostate cancer patients undergoing radical prostatectomy by combining multiparametric MRI and machine learning techniques. The combination of multi-parametric MRI and machine learning (validated using histopathology) can lead to increased sensitivity and specificity of cancer foci in the prostate, and help in isolating aggressive from indolent tumors. This increased sensitivity and specificity may eventually lead to: a) a reduction in the number of patients that undergo unnecessary treatment, and b) enhance current treatment options by enabling the use of focused therapies. The investigators will recruit 15 patients with prostate cancer that are currently scheduled to undergo radical prostatectomy into the study. All patients will obtain an advanced MRI study prior to the radical prostatectomy. MRI scans will include a) high-resolution volumetric images using T1 and T2-weighted imaging, b) vascular images using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. Following radical prostatectomy, a pathologist will grade the prostatectomy specimens based on standard of care (Gleason grading system). Correlations will be generated between the parameters obtained from scans and from clinical assessments.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All male patients that have opted for radical prostatectomy
  • Subjects must be capable of giving informed consent.
  • Subjects must not be claustrophobic.

排除标准

  • Subjects with pacemakers.
  • Subjects who have metallic ferromagnetic implants or pumps.
  • All females are excluded from this study.
  • Subjects with kidney disease of any severity or on hemodialysis.
  • Subjects with known allergies to gadolinium-based contrast agents.
  • Subjects incapable of lying on their backs for up to an hour at a time.

结局指标

主要结局

Primary Objective: distinguishing high-grade tumors vs. low-grade tumors and normal prostate

时间窗: 16 months

Whether advanced MR imaging techniques can be used to train machine-learning techniques to distinguish high-grade tumors from low-grade tumors and normal prostate. The machine-learning techniques will be trained using histopathology data as the ground truth. To achieve this we will obtain volumetric images of the various tissue attributes (listed below) and match them to histopathology: * Vascular permeability (ktrans) using dynamic contrast enhanced MRI (DCE-MRI) * Morphological changes captured using T2 and diffusion changes using diffusion weighted MRI (DW-MRI) * Metabolic signatures of (choline+creatine)/citrate) or CC/C using magnetic resonance spectroscopic imaging (MRSI) * Correlate in vivo imaging findings to ex vivo histopathology using deformable image registration * Develop a multiclass support vector machine (SVM) using the set of multi-parametric images as input, and use it predict a score akin to the Gleason score.

次要结局

  • Secondary Objective: non-invasive and quantitative test to accurately identify the tumor grade and location.(16 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Department of Radiation Oncology

Principal Investigator

University of Maryland, Baltimore

研究点 (1)

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