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

Prostate in Healthy Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190344
• Other study ID #: 019-2014
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: April 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate in Healthy Males

Intervention

Device:
• 8-channel paddle coil
MRI Coil

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Ontario Institute for Cancer Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of Coil to produce MRI images	functional with adequate SNR; functional with non-adequate SNR; non-functional	1 hour