Testing of Radiofrequency Coil for Clinical 19F MRI

Diagnostic Imaging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687750
• Other study ID #: RRI-PF-001
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: February 16, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Testing of a dual tuned proton/fluorine MRI radio frequency coil

Images were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers.

This trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy Volunteer

Exclusion Criteria:

• MRI incompatible patient

• claustrophobia

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Device:
• MRI
Investigational device is a dual tuned (fluorine/proton) MRI surface coil designed and produced by Clinical MR solutions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verify radio frequency coil imaging functionality on humans	Proof of successful MRI signal acquisition with use of investigation device.	1 hour of scanning	No
Primary	Measure signal repeatability in different patients	MRI signal strength is expected to vary slightly based on patient weight.	1 hour of scanning	No