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Completed

NCT Number: NCT01156987

Improved Breast MRI With SWIFT

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Magnetic Resonance Research

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnetic Resonance Imaging

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.

Other names: SWIFT

Primary outcomes

  1. Lesions

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

    Number of lesions detected

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jul 5, 2010
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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