Testing of Radiofrequency Coil for Clinical 19F MRI

February 16, 2016 updated by: Paula Foster, Western University, Canada

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Volunteer

Exclusion Criteria:

  • MRI incompatible patient
  • claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI

Eppendorf tubes containing 10% fluorine-19 diluted in agar were taped to the upper thigh of participants. Investigational device was used to image the phantom with Magnetic resonance imaging (MRI). Imaging was performed for anatomical (proton) and fluorine (agent detection). Total scan time was under 1 hour.

Objectives:

  • Verify RF coil functionality
  • Obtain preliminary detection threshold limits using a human coil loading
Device: MRI
Investigational device is a dual tuned (fluorine/proton) MRI surface coil designed and produced by Clinical MR solutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify radio frequency coil imaging functionality on humans
Time Frame: 1 hour of scanning
Proof of successful MRI signal acquisition with use of investigation device.
1 hour of scanning
Measure signal repeatability in different patients
Time Frame: 1 hour of scanning
MRI signal strength is expected to vary slightly based on patient weight.
1 hour of scanning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • RRI-PF-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diagnostic Imaging

Clinical Trials on MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe