Improved Breast MRI With SWIFT

January 26, 2017 updated by: University of Minnesota

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Center for Magnetic Resonance Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers
Five healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Device: 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.

Other Names:
  • SWIFT
Experimental: 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.
Device: 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.

Other Names:
  • SWIFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesions
Time Frame: at time of read by two radiologiests, compared to biopsy within 7 days.
Number of lesions detected
at time of read by two radiologiests, compared to biopsy within 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Curtis Corum, Ph.D., Masonic Cancer Center, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2009NTLS055
  • 0907M69461 (Other Identifier: IRB, University of Minnesota)
  • 1R21CA139688 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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