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临床试验/NCT01401972
NCT01401972已完成不适用

Conventional and Contrast-Assisted Frequency Functional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
ultrasound backscatter parameters such as aggregate mid-band fit, spectroscopic slope and intercept and the number of vessels with detectable blood flow and their sizes

研究概览

简要总结

In this observational study the investigators will undertake imaging studies on men with prostate cancer. The primary hypothesis is that ultrasound spectroscopy could be used to determine the extent of disease inside and outside of the prostate gland in patients with prostate cancer. It is hoped that the changes in ultrasound backscatter parameters obtained before radical prostatectomy could be used to correlate with pathological findings from the prostate specimen after surgery.

详细描述

This project is an early validation study in human subjects that will use ultrasound imaging and spectroscopy to predict the tumour extent before treatment so that this may allow the most appropriate treatment intervention to be individualised to patients. For examples, patients with evidence of extra-prostatic tissue involvement may be best served with definitive radiation therapy rather than radical prostatectomy as surgery alone in this situation, is not optimum. Furthermore, these ultrasound parameters may be used to monitor cell death occurring at various time points during patients' radiation treatment for prostate cancer.

The research is exploratory since upon data analysis it will examine the use of different ultrasound parameters as potential markers of pre-treatment tumour extent and cell death, and correlate these with tumour shrinkage and complete pathological response. Sensitivity and specificity values for the various ultrasound parameters will be calculated for the different time points used and receiver-operator curves will be generated. From this data the investigators will potentially estimate the best time-points at which to make a prediction about patient response and the best ultrasound-spectroscopy variables to use for this purpose.

研究设计

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

入排标准

性别
Male
接受健康志愿者

入选标准

  • Prostate Cancer

排除标准

  • Not having radical prostatectomy surgery

结局指标

主要结局

ultrasound backscatter parameters such as aggregate mid-band fit, spectroscopic slope and intercept and the number of vessels with detectable blood flow and their sizes

时间窗: Up to year 2019

These parameters will be obtained before radical prostatectomy to correlate with pathological findings from the prostate specimen after surgery.

次要结局

  • sensitivity and specificity of ultrasound-based imaging of the prostate(Up to year 2019)

研究者

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

Dr. Gregory Czarnota

Dr.

Sunnybrook Health Sciences Centre

研究点 (1)

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