Novel MRI Sequence- MR Fingerprinting

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.

Study Overview

• Status: Completed
• Conditions: Disease
• Intervention / Treatment: Device: MR Fingerprinting

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients With Visible Region of Interest (Imaging Visibility)	MR fingerprinting sequences will be examined to determine their utility for visualizing pathology.	Immediately following MRI completion, within approximately 5 minutes

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: William Hyslop, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 17-2731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No