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临床试验/NCT02190344
NCT02190344已完成不适用

Study to Evaluate the Functionality of an Eight-Channel Paddle Coil System Using MRI

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
1
主要终点
Ability of Coil to produce MRI images

研究概览

简要总结

The objective of this study is to determine the functionality of an eight-channel paddle coil system which is to be used in future MRI studies.

详细描述

Prostate cancer is the most common malignancy among men and the second leading cause of cancer death in men. Currently, MRI is the best imaging modality for both detecting prostate cancer and determining the presence of extra-prostatic extension. Multiparametric Magnetic Resonance, combining T2-weighted, diffusion-weighted and dynamic contrast enhanced imaging (DCE-MRI) is recommended as the minimum acceptable standard for prostate MRI examination. However, MPMRI still lacks diagnostic accuracy in the transition zone, where distinguishing cancer from proliferative nodules has proven difficult. DCE-MRI techniques evaluate the time course of signal intensities after administration of a contrast medium and have been used to successfully differentiate benign from malignant tumours, particularly in breast and prostate cancer. Unfortunately, current DCE approaches have high false-positive rates and are limited in distinguishing prostatitis and vascularized BPH nodules from cancer in active surveillance studies. Future studies that employ spectroscopic MR imaging of the prostate after administration of Hyperpolarized (13C) Pyruvate Injection, are expected to provide a robust, non-invasive method to assist in detecting and characterizing prostate cancer. The objective of this study is to determine the functionality of an eight-channel paddle coil system which is to be used in future Hyperpolarized (13C) Pyruvate Injection studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy male volunteers between 18 and 80 years of age

排除标准

  • •Any contra-indication for MR imaging (such as pacemakers, surgical implants, foreign metal objects in the body)

研究组 & 干预措施

Functionality of 8-channel paddle coil system

Experimental

干预措施: 8-channel paddle coil (Device)

结局指标

主要结局

Ability of Coil to produce MRI images

时间窗: 1 hour

1. functional with adequate SNR 2. functional with non-adequate SNR 3. non-functional

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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