Improved Breast MRI With SWIFT
Improved Breast Dynamic Contrast Enhanced-magnetic Resonance Imaging (DCE-MRI) With Sweep Imaging With Fourier Transform (SWIFT)
3 other identifiers
interventional
31
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Aug 2009
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 2, 2010
CompletedFirst Posted
Study publicly available on registry
July 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
December 19, 2016
CompletedMarch 9, 2017
January 1, 2017
6 years
July 2, 2010
December 9, 2015
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Lesions
Number of lesions detected
at time of read by two radiologiests, compared to biopsy within 7 days.
Study Arms (2)
Healthy Volunteers
EXPERIMENTALFive healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Breast Cancer Patients
EXPERIMENTAL40 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Center for Magnetic Resonance Research
Minneapolis, Minnesota, 55455, United States
Related Publications (4)
Corum CA, Idiyatullin D, Snyder CJ, Garwood M. Gap cycling for SWIFT. Magn Reson Med. 2015 Feb;73(2):677-82. doi: 10.1002/mrm.25141. Epub 2014 Feb 24.
PMID: 24604286BACKGROUNDIdiyatullin D, Corum C, Park JY, Garwood M. Fast and quiet MRI using a swept radiofrequency. J Magn Reson. 2006 Aug;181(2):342-9. doi: 10.1016/j.jmr.2006.05.014. Epub 2006 Jun 19.
PMID: 16782371BACKGROUNDNelson MT, Benson JC, Prescott T, Corum CA, Snyder A, Garwood M. Breast MRI using SWeep Imaging with Fourier Transform (SWIFT). Eur J Radiol. 2012 Sep;81 Suppl 1(0 1):S109. doi: 10.1016/S0720-048X(12)70044-X. No abstract available.
PMID: 23083549RESULTCorum CA, Benson JC, Idiyatullin D, Snyder AL, Snyder CJ, Hutter D, Everson LI, Eberly LE, Nelson MT, Garwood M. High-spatial- and high-temporal-resolution dynamic contrast-enhanced MR breast imaging with sweep imaging with Fourier transformation: a pilot study. Radiology. 2015 Feb;274(2):540-7. doi: 10.1148/radiol.14131273. Epub 2014 Sep 22.
PMID: 25247405RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Curt Corum
- Organization
- University of MN
Study Officials
- PRINCIPAL INVESTIGATOR
Curtis Corum, Ph.D.
Masonic Cancer Center, University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2010
First Posted
July 5, 2010
Study Start
August 1, 2009
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
March 9, 2017
Results First Posted
December 19, 2016
Record last verified: 2017-01