Novel MRI Sequence- MR Fingerprinting

NCT ID: NCT03722459

Last Updated: 2022-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-02
• Study Completion Date: 2022-09-09

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.

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.

Conditions

Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All participants

All participants will receive the investigational MR Fingerprinting sequence.

Group Type: EXPERIMENTAL

MR Fingerprinting

Intervention Type: DEVICE

The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.

Interventions

MR Fingerprinting

The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Hyslop, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

17-2731

Identifier Type: -

Identifier Source: org_study_id