Improved Breast MRI With SWIFT

University of Minnesota (UMN)

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Magnetic resonance imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01156987

2009NTLS055

1R21CA139688 (U.S. NIH Grant/Contract)

0907M69461 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Healthy Volunteers

Experimental group

Description:

Five healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.

Treatment:

Device: Magnetic resonance imaging

Breast Cancer Patients

Experimental group

Description:

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.

Treatment:

Device: Magnetic resonance imaging