Improved Breast Dynamic Contrast Enhanced-magnetic Resonance Imaging (DCE-MRI) With Sweep Imaging With Fourier Transform (SWIFT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Lesions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Healthy Volunteers
Five healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Intervention: Magnetic resonance imaging (Device)
Breast Cancer Patients
40 breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.
Intervention: Magnetic resonance imaging (Device)
Outcomes
Primary Outcomes
Lesions
Time Frame: at time of read by two radiologiests, compared to biopsy within 7 days.
Number of lesions detected
Secondary Outcomes
No secondary outcomes reported