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Completed

NCT Number: NCT02190344

Functionality of an 8-Channel Paddle Coil for Use With MRI

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers between 18 and 80 years of age

Exclusion criteria

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

Treatment and study plan

8-channel paddle coil

Device

MRI Coil

Primary outcomes

  1. Ability of Coil to produce MRI images

    Time frame: 1 hour

    • functional with adequate SNR
    • functional with non-adequate SNR
    • non-functional

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Ontario Institute for Cancer Research

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2014
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.