Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study

NCT03846947 | Completed Results FDA Device

• 1 other identifier: LCCC1853
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Screening

Outcome Measures

Primary Outcomes (3)

• Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence

  The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T1 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T1 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.

  during MRI, approximately 1 hour

• Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence

  The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T2 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T2 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.

  during MRI, approximately 1 hour

• Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence

  The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the investigational (MRF) sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of MRF relaxation time.

  during MRI, approximately 1 hour

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

All participants

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Director, Clinical Research, Department of Radiology
• Organization: UNC Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Cherie Kuzmiak, DO,FACR,FSBI

  UNC 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: February 18, 2019
• First Posted: February 20, 2019
• Study Start: February 18, 2019
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: May 11, 2023
• Results First Posted: May 11, 2023

Record last verified: 2023-04

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)