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Novel MRI Sequence- MR Fingerprinting

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ClinicalTrials.gov Identifier: NCT03722459
Recruitment Status : Suspended (Study suspended due to COVID-19 restrictions. Study will be resumed once plans for appropriate social distancing are in place.)
First Posted : October 29, 2018
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Magnetic Resonance Imaging (MRI) has become one of most important medical imaging tools over the past 30 years because it is non-invasive, requires no ionizing radiation, and provides exquisite images of soft tissues and anatomic structures with many tissue/disease specific contrasts. While MRI has served the community well for many years, it is increasingly clear that it also has significant limitations.

One of the principle limitations is the lack of quantitative information for tissue/structure characterization. The current paradigm of MRI is to use a set of scanner settings to generate an image "weighted" by a specific MR contrast mechanism (physical parameter), where it is hoped that variations in the parameter will be accentuated. However, without quantitative knowledge of the parameters, the final image contrast may depend on many factors, which complicates image interpretation and diagnostic performance. Quantitative measurement can provide a great deal of information about tissue properties and pathological conditions, since these parameters ultimately determine the contrast that is observed in conventional images.


Condition or disease Intervention/treatment Phase
Disease Device: MR Fingerprinting Not Applicable

Detailed Description:
The purpose of this study is to evaluate novel quantitative MRI techniques in clinical studies to determine whether they can provide better, faster and more useful information for clinical diagnosis. In this study, the investigators propose to apply MR Fingerprinting and evaluate its performance for different diseases. These include, but are not limited to, diseases in the liver, kidney, cardiac, pancreas etc. The investigators hypothesize that the quantitative MR Fingerprinting imaging technique will lead to improved tissue characterization and diagnosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Novel MRI Sequence- MR Fingerprinting
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: All participants
All participants will receive the investigational MR Fingerprinting sequence.
Device: MR Fingerprinting
The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.




Primary Outcome Measures :
  1. Percent of Patients with Visible Region of Interest (Imaging Visibility) [ Time Frame: Immediately following MRI completion, within approximately 5 minutes ]
    MR fingerprinting sequences will be examined to determine their utility for visualizing pathology.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The study will include English-speaking patients that are already scheduled to undergo a clinical MRI for diagnostic purposes.

Exclusion Criteria:

  • Pregnant women will be excluded.
  • Women will be excluded from the healthy volunteers, due to a lack of funding for pregnancy testing. Funding for this will be considered for the future.

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): NCT03722459


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: William Hyslop, MD, PhD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03722459    
Other Study ID Numbers: 17-2731
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Time Frame: 9 to 36 months following publication
Access Criteria: The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No