Novel MRI Sequence- MR Fingerprinting

NCT03722459 | Completed Results FDA Device

• 1 other identifier: 17-2731
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All participants

EXPERIMENTAL

All participants will receive the investigational MR Fingerprinting sequence.

Device: MR Fingerprinting

Interventions

MR Fingerprinting DEVICE

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

All participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Research, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• William Hyslop, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: November 2, 2018
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: December 20, 2022
• Results First Posted: December 20, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)