Breast CancerNCT01156987
Improved Breast MRI With SWIFT
A study testing Magnetic resonance imaging in people with Breast Cancer, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.
Who cannot join
- Pregnancy
- Ferromagnetic implants
- History of shotgun wounds and shrapnel
- Obesity (>250 pounds)
- Cardiac pacemaker
- Incompatible implanted medical device
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Magnetic Resonance Research
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Magnetic resonance imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDevice
Also called SWIFT
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Five healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition. Receives: Device: Magnetic resonance imaging |
| Breast Cancer Patients | Experimental | 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. Receives: Device: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions
Number of lesions detected
Measured: at time of read by two radiologiests, compared to biopsy within 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Curtis Corum, Ph.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156987
- Sponsor's protocol ID
- 2009NTLS055
- Other IDs
- 0907M69461, 1R21CA139688
- Status last verified
- Jan 2017
- First submitted
- 2 Jul 2010
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24604286Idiyatullin 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.
PubMed 16782371Nelson 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.
PubMed 23083549Corum 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.
PubMed 25247405
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Breast Dynamic Contrast Enhanced-magnetic Resonance Imaging (DCE-MRI) With Sweep Imaging With Fourier Transform (SWIFT)
- ClinicalTrials.gov ID
- NCT01156987
- Acronym / sponsor ID
- 2009NTLS055
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 19 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: Magnetic resonance imagingFive healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition. |
| Breast Cancer Patients | Experimental | Device: Magnetic resonance imaging40 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.
Key exclusion criteria (12 listed)
- Pregnancy
- Ferromagnetic implants
- History of shotgun wounds and shrapnel
- Obesity (>250 pounds)
- Cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingAlso: SWIFTPatients 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. | Device | Breast Cancer Patients, Healthy Volunteers |
Primary outcome
Lesions
Time frame: at time of read by two radiologiests, compared to biopsy within 7 days.
Number of lesions detected
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24604286Corum 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.
- Background: PubMed 16782371Idiyatullin 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.
- Results publication: PubMed 23083549Nelson 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.
- Results publication: PubMed 25247405Corum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis Corum, Ph.D. principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging in people with Breast Cancer, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesions (time frame: at time of read by two radiologiests, compared to biopsy within 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01156987, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.