Novel MRI Sequence- MR Fingerprinting

• ClinicalTrials.gov Identifier: NCT03722459
• Recruitment Status: Suspended
• First Posted: October 29, 2018
• Last Update Posted: January 15, 2021
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

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

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03722459
• Other Study ID Numbers: 17-2731
• First Posted: October 29, 2018
• 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.

• 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