Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study

NCT ID: NCT03846947

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2022-06-21

Brief Summary

The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast Enhanced (DCE) MRI for high risk normal patients.

Detailed Description

This is a feasibility study of the use of the additional MR fingerprinting (MRF) scanning sequence with a total of 12 minutes scanning time to our clinical screening breast DCE MRI examination before contrast medium injection and at the end of scan. This additional scanning sequence may provide faster and better quantitative tissue characterization comparing to conventional MR sequences. There is no investigational contrast agent in this study. We propose that the additional MRF sequence may provide faster and more accurate tissue characteristics imaging for clinical evaluation of breast tissue. Patients will be enrolled in with scheduled high risk screening DCE MRI (n=30). The MR imaging will be performed in the clinical 1.5T MR scanners in UNC as normally done for the patients MRI schedule. We only add an additional MRF sequence within the MRI exam just prior to the contrast enhancement scan.

Quantitative measurement of the breast tissue will be performed after the MR exam. The region-of-interest (ROI) of normal breast parenchyma was recorded. The ROI will be saved and encoded to the T1 map, T2 map in MRF, T1 weighted imaging, T2 weighted imaging. A large variety of imaging ROI-based quantitative measures will be calculated among normal glands in bilateral breasts to evaluate different ROI characteristics among different patients and between bilateral breasts in each patient.

Conditions

Breast Screening

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 total and will be added before and after the standard MRI sequence.

Interventions

MR Fingerprinting

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• English-speaking patients
• Ages 18 to 99 years old
• Scheduled to undergo a screening breast MRI study
• Capable and willing to provide signed informed consent

Exclusion Criteria

• Claustrophobia
• Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
• Known hypersensitivity to contrast agent or to any component of contrast agent refractory to standard medications (antihistamines, steroids)
• Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
• Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
• Pregnancy or lactating female
• Previous history of mastectomy or lumpectomy
• Breast enhancements (i.e. implants)

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

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cherie Kuzmiak, DO,FACR,FSBI

Role: PRINCIPAL_INVESTIGATOR

UNC 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 and Statistical Analysis Plan

View Document

Other Identifiers

LCCC1853

Identifier Type: -

Identifier Source: org_study_id