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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Jadranka Stojanovska, M.D., M.S., University of Michigan Identifier:
First received: July 28, 2008
Last updated: January 21, 2017
Last verified: January 2017
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
Magnetic Resonance Imaging (MRI) of the Chest
Procedure: MRI -Clinical
Procedure: MRI-Research

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.

Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00727792

United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: Jadranka Stojanovska, MD University of Michigan
  More Information

Responsible Party: Jadranka Stojanovska, M.D., M.S., Principal Investigator, University of Michigan Identifier: NCT00727792     History of Changes
Other Study ID Numbers: HUM00041512
Study First Received: July 28, 2008
Last Updated: January 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Michigan:
MRI processed this record on May 23, 2017