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

Not Applicable

Completed

• Conditions: Magnetic Resonance Imaging (MRI) of the Chest
• Interventions: Procedure: MRI-Research; Procedure: MRI -Clinical

• Registration Number: NCT00727792
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of the study is to improve chest MRI exams, eventually resulting in improvements in patient care.

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 Timeline

• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Study Start: 2009-01
• Primary Completion: 2019-04-16
• Study Completion: 2019-04-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2 - Research MRI	MRI-Research	Subjects will have additional sequences and/or modification to MRI sequences.
Group 1 - Clinical MRI	MRI -Clinical	Clinically ordered MRI scan. Subjects will not have any additional sequences or modifications to their clinically ordered MRI

Primary Outcome Measures

Name	Time	Method
New MRI Technologies	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States