Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study



Status:Recruiting
Healthy:No
Age Range:18 - 99
Updated:4/4/2019
Start Date:February 18, 2019
End Date:February 18, 2020
Contact:Terry Hartman, MS,MPH
Email:terry_hartman@med.unc.edu
Phone:919-966-4997

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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.

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.

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)
We found this trial at
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site
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-843-9463
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