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

Not Applicable

Completed

• Conditions: Prostate in Healthy Males
• Interventions: Device: 8-channel paddle coil

• Registration Number: NCT02190344
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functionality of 8-channel paddle coil system	8-channel paddle coil	-

Primary Outcome Measures

Name	Time	Method
Ability of Coil to produce MRI images	1 hour	1. functional with adequate SNR; 2. functional with non-adequate SNR; 3. non-functional

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada