Clinical trial NCT01156987: Improved Breast MRI With SWIFT
Official title: Improved Breast Dynamic Contrast Enhanced-magnetic Resonance Imaging (DCE-MRI) With Sweep Imaging With Fourier Transform (SWIFT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-07-05
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Today's medical imaging methods have insufficient specificity for reliable differentiation between benign and malignant breast lesions in patients. Pathologic evaluation is currently the only way to obtain a definitive diagnosis. This research will use a novel method of magnetic resonance imaging (MRI), Sweep Imaging with Fourier Transform (SWIFT), at a very high magnetic field (4 Tesla) to distinguish malignant from benign breast lesions. This research will reveal whether the SWIFT sequence bears new capabilities in medical imaging for breast cancer diagnosis.

Detailed description: Patients will be asked to come to the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Researchers will interview the patient and describe procedures and risks. An intravenous (IV) line will be placed in an upper extremity for infusing magnetic resonance imaging (MRI) contrast dye. Baseline MRI scans will be done. These MRI measurements will be compared with clinical, radiological and pathological findings (the gold standard).

Follow-up contact will occur within one year after the MRI to determine whether a pathology report is available.

Eligibility criteria: Inclusion Criteria:

* Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.

Exclusion Criteria:

* Pregnancy
* Ferromagnetic implants
* History of shotgun wounds and shrapnel
* Obesity (\>250 pounds)
* Cardiac pacemaker
* Incompatible implanted medical device
* Severe claustrophobia
* Major surgeries with potential of ferromagnetic implants
* Severe asthma and allergies
* i-STAT system, a handheld blood analyzer (I-STAT) creatinine test, estimated glomerular filtration rate (GFR) \<30
* Metallic object (greater than 2 cm in length) in the breast
* Metallic ink tatoo within 20 cm of the breast (approximately 8 inches)

Primary outcomes:
measure: Lesions
timeFrame: at time of read by two radiologiests, compared to biopsy within 7 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Center for Magnetic Resonance Research
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Curtis Corum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corum CA, Idiyatullin D, Snyder CJ, Garwood M. Gap cycling for SWIFT. Magn Reson Med. 2015 Feb;73(2):677-82. doi: 10.1002/mrm.25141. Epub 2014 Feb 24.
citation: Idiyatullin D, Corum C, Park JY, Garwood M. Fast and quiet MRI using a swept radiofrequency. J Magn Reson. 2006 Aug;181(2):342-9. doi: 10.1016/j.jmr.2006.05.014. Epub 2006 Jun 19.
citation: Nelson MT, Benson JC, Prescott T, Corum CA, Snyder A, Garwood M. Breast MRI using SWeep Imaging with Fourier Transform (SWIFT). Eur J Radiol. 2012 Sep;81 Suppl 1(0 1):S109. doi: 10.1016/S0720-048X(12)70044-X. No abstract available.
citation: Corum CA, Benson JC, Idiyatullin D, Snyder AL, Snyder CJ, Hutter D, Everson LI, Eberly LE, Nelson MT, Garwood M. High-spatial- and high-temporal-resolution dynamic contrast-enhanced MR breast imaging with sweep imaging with Fourier transformation: a pilot study. Radiology. 2015 Feb;274(2):540-7. doi: 10.1148/radiol.14131273. Epub 2014 Sep 22.