N/A
N=31
Improved Breast MRI With SWIFT
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01156987 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Lesions — 0; 12 lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic resonance imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Minnesota
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesions |
0; 12 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01156987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.