Improved Breast MRI With SWIFT

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01156987
First received: July 2, 2010
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Device: Magnetic resonance imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Improved Breast Dynamic Contrast Enhanced-magnetic Resonance Imaging (DCE-MRI) With Sweep Imaging With Fourier Transform (SWIFT)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Optimize Sweep Imaging with Fourier Transform magnetic resonance imaging (SWIFT MRI) for Breast [ Time Frame: Baseline (7/2010 - 12/2010) ] [ Designated as safety issue: No ]
    Optimization and validation of the basic SWIFT sequence - develop guidelines for minimal clinical implementation.


Secondary Outcome Measures:
  • Assess Accuracy Relative to Biopsy [ Time Frame: Baseline Compared to End of Study ] [ Designated as safety issue: No ]
    Comparison of magnetic resonance imaging (MRI) results to pathological findings.


Estimated Enrollment: 45
Study Start Date: August 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: SWIFT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156987

Contacts
Contact: Diane Hutter, RN 612-625-2350 hutte019@umn.edu

Locations
United States, Minnesota
Center for Magnetic Resonance Research Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Diane Hutter, RN    612-625-2350    hutte019@umn.edu   
Principal Investigator: Curtis Corum, Ph.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Curtis Corum, Ph.D. Masonic Cancer Center, University of Minnesota
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01156987     History of Changes
Other Study ID Numbers: 2009NTLS055, 0907M69461, 1R21CA139688
Study First Received: July 2, 2010
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014