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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00727792
Recruitment Status : Enrolling by invitation
First Posted : August 4, 2008
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Magnetic Resonance Imaging (MRI) of the Chest Procedure: MRI -Clinical Procedure: MRI-Research

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams
Study Start Date : January 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727792


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

Responsible Party: Jadranka Stojanovska, M.D., M.S., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00727792     History of Changes
Other Study ID Numbers: HUM00041512
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jadranka Stojanovska, M.D., M.S., University of Michigan:
participants
scheduled
clinically
ordered
MRI