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Clinical Trials/NCT01156987
NCT01156987
Completed
Not Applicable

Improved Breast Dynamic Contrast Enhanced-magnetic Resonance Imaging (DCE-MRI) With Sweep Imaging With Fourier Transform (SWIFT)

University of Minnesota1 site in 1 country31 target enrollmentAugust 2009
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Minnesota
Enrollment
31
Locations
1
Primary Endpoint
Lesions
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
August 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Lesions

Time Frame: at time of read by two radiologiests, compared to biopsy within 7 days.

Number of lesions detected

Study Sites (1)

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