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Improved Breast MRI With SWIFT

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Device: Magnetic resonance imaging
Registration Number
NCT01156987
Lead Sponsor
University of Minnesota
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
31
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Healthy VolunteersMagnetic resonance imagingFive healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Breast Cancer PatientsMagnetic resonance imaging40 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.
Primary Outcome Measures
NameTimeMethod
Lesionsat time of read by two radiologiests, compared to biopsy within 7 days.

Number of lesions detected

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Center for Magnetic Resonance Research

🇺🇸

Minneapolis, Minnesota, United States

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