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

July 28, 2008
March 11, 2013
January 2009
September 2014   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00727792 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams
Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Study Focus-Magnetic Resonance Imaging of the Chest
Procedure: MRI
  • Experimental: Group 2
    Additional sequences and/or modification to sequences will be added.
    Intervention: Procedure: MRI
  • Active Comparator: Group 1
    Clinically ordered MRI scan (NON MODIFIED)
    Intervention: Procedure: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
September 2015
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00727792
HUM00041512
Not Provided
Gisela Mueller, MD, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Gisela Mueller, MD University of Michigan
University of Michigan
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP