Improved Breast MRI With SWIFT

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

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

Group Type EXPERIMENTAL

Magnetic resonance imaging

Intervention Type DEVICE

Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:

* an IV line is placed by nurse,
* patient is placed in the 4 T MRI scanner at CMRR,
* initial scout images and manual linear shims are adjusted,
* Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
* continuous SWIFT acquisition begins immediately before contrast injection,
* contrast injection,
* continuous SWIFT acquisition continues for 12 min after contrast,
* late enhancement images may also be obtained.

10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.

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.

Group Type EXPERIMENTAL

Magnetic resonance imaging

Intervention Type DEVICE

Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:

* an IV line is placed by nurse,
* patient is placed in the 4 T MRI scanner at CMRR,
* initial scout images and manual linear shims are adjusted,
* Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
* continuous SWIFT acquisition begins immediately before contrast injection,
* contrast injection,
* continuous SWIFT acquisition continues for 12 min after contrast,
* late enhancement images may also be obtained.

10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.

Interventions

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Magnetic resonance imaging

Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:

* an IV line is placed by nurse,
* patient is placed in the 4 T MRI scanner at CMRR,
* initial scout images and manual linear shims are adjusted,
* Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
* continuous SWIFT acquisition begins immediately before contrast injection,
* contrast injection,
* continuous SWIFT acquisition continues for 12 min after contrast,
* late enhancement images may also be obtained.

10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.

Intervention Type DEVICE

Other Intervention Names

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SWIFT

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes