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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gisela Mueller, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00727792
First received: July 28, 2008
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

The purpose of the study is to improve MRI examinations of the chest region that will result in an improvement in patient care.


Condition Intervention
Study Focus-Magnetic Resonance Imaging of the Chest
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • New MRI Technologies [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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.


Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
Additional sequences and/or modification to sequences will be added.
Procedure: MRI
Active Comparator: Group 1
Clinically ordered MRI scan (NON MODIFIED)
Procedure: MRI

Detailed Description:

To establish an approved mechanism to recruit patients to participate in the assessment of new MRI technologies designed to improve MRI examinations of the chest region that will result in an improvement in patient care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 lactating.
  • Patients who are claustrophobic.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727792

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Gisela Mueller, MD University of Michigan
  More Information

No publications provided

Responsible Party: Gisela Mueller, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00727792     History of Changes
Other Study ID Numbers: HUM00041512
Study First Received: July 28, 2008
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
focus
participants
scheduled
clinically
ordered
MRI

ClinicalTrials.gov processed this record on April 17, 2014