Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams

January 17, 2020 updated by: Jadranka Stojanovska, M.D., M.S., University of Michigan
The purpose of the study is to improve chest MRI exams, eventually resulting in improvements in patient care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will recruit patients to participate in the assessment of new MRI technologies designed to improve chest MRI exams that will result in improvements in patient care.

Several different MRI technologies will be evaluated. Specific evaluation of distinct technologies (eg. new head coil design, and new imaging sequence for the spine) may be evaluated simultaneously, or over non-overlapping periods in time.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • If you are a male or a non-pregnant female patient, age 18 years or older, of any ethnic background presenting to MRI for a clinically-ordered chest MRI exam, you are eligible to participate in this study.
  • If you are a female of child bearing potential you will be questioned for the possibility of pregnancy. Pregnancy screening, if necessary, is performed routinely by ordering physicians prior to MRI scanning to confirm the patient is not pregnant.

Exclusion Criteria:

  • Patients who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
  • Pregnant patients or patients who are nursing
  • Patients who are claustrophobic.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2 - Research MRI
Subjects will have additional sequences and/or modification to MRI sequences.
Procedure: MRI-Research
MRI includes extra sequences
Active Comparator: Group 1 - Clinical MRI
Clinically ordered MRI scan. Subjects will not have any additional sequences or modifications to their clinically ordered MRI
Procedure: MRI -Clinical
MRI done is standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New MRI Technologies
Time Frame: 3 years

Assessment of the new technologies will be quantified by a variety of performance and image quality/content measures. The appropriate set of measures will be selected based on specific features offered by each assessed technology, but will be drawn from the following quantities:

  1. Scan speed: Scan speed is time required to set-up and run the new technique relative to the standard method.
  2. Signal to noise: SNR (signal to noise ratio)is the ratio of average image intensity in target tissue relative to standard deviation of background areas (outside of body). This is a fundamental parameter used to quantify relative performance of new imaging sequences/hardware/software.
  3. Contrast to noise: CNR (contrast to noise)is the difference in average image intensity between two target tissues relative to noise. This is a key descriptor to quantity lesion/tissue conspicuity, thus is used to characterize relative performance of new imaging sequence/hardware/software.
3 years

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Jadranka Stojanovska, MD, University of Michigan

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 (Actual)

January 1, 2009

Primary Completion (Actual)

April 16, 2019

Study Completion (Actual)

April 16, 2019

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

August 1, 2008

First Posted (Estimate)

August 4, 2008

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00041514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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