Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer
NCT ID: NCT01938651
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2013-01-31
2015-06-30
Brief Summary
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Detailed Description
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I. To implement quantitative dynamic contrast-enhanced (DCE)-MRI, diffusion-weighted (DW)-MRI, 31 phosphorus (31P) MRS, magnetization transfer (MT)-MRI, chemical exchange saturation transfer (CEST)-MRI, and high-resolution structural imaging at 7 Tesla in patients for diagnosing breast tumors.
OUTLINE:
Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. Diagnostic performance of one, or a combination, of these metrics will be investigated in the context of breast cancer.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (7T ultra high-field MRI/MRS)
Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. All of these procedures are integrated into a single MRI exam lasting under 60 min.
high field strength magnetic resonance imaging
Undergo 7T MRI
magnetic resonance spectroscopic imaging
Undergo 31P MRS
chemical exchange saturation transfer magnetic resonance imaging
Undergo CEST-MRI
diffusion-weighted magnetic resonance imaging
Undergo DW-MRI
dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Interventions
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high field strength magnetic resonance imaging
Undergo 7T MRI
magnetic resonance spectroscopic imaging
Undergo 31P MRS
chemical exchange saturation transfer magnetic resonance imaging
Undergo CEST-MRI
diffusion-weighted magnetic resonance imaging
Undergo DW-MRI
dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be at least 18 years old
* Subjects must have undergone x-ray mammography and/or ultrasonography
* Subjects must have undergone standard clinical (1.5 Tesla) MRI as part of their standard-of-care diagnostic workup:
* To evaluate the extent of disease for a previously diagnosed cancer, or
* To evaluate a clinically suspected lesion that was occult on mammography and/or ultrasonography, or
* Because the patient is considered high-risk (according to National Comprehensive Cancer Network \[NCCN\] criteria)
* Subjects must be classified Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5
* Subjects must be scheduled for diagnostic biopsy to evaluate a lesion that measures \>10 mm in the greatest dimension.
Exclusion Criteria
* Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, aneurysm clip, etc), because such devices may be displaced or malfunction
* Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced by the magnetic field of the MRI scanner
* Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes)
* Subjects with a history of renal disease (including renal cancer), diabetes, or human immunodeficiency virus (HIV)
* Creatinine \>= 1.5 times upper limit of normal
* Estimated glomerular filtration rate \< 30 mL/min
* Subjects who are pregnant or breast-feeding; the MRI Procedure Screening Form will be used to identify and exclude subjects who are pregnant or breastfeeding; a urine pregnancy test/or serum human chorionic gonadotropin (HCG) will also be performed for pre-menopausal women who are not using contraceptives
* Subjects who have exhibited past allergic or other adverse reactions in response to intravenous injection of Magnevist (gadopentetate dimeglumine) or other gadolinium-containing contrast agents
* Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
* Subjects incapable of giving informed written consent, for the following reasons:
* Inability to adhere to the experimental protocols for any reason
* Inability to communicate with the research team
* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
* Prisoners or other individuals deemed to be susceptible to coercion
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Thomas Yankeelov
Director of Cancer Imaging Research, Vanderbilt University Institute of Imaging Science (VUIIS); Associate Professor of Radiology and Radiological Sciences, Biomedical Engineering, Physics and Astronomy, and Cancer Biology;
Principal Investigators
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Thomas Yankeelov
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Related Links
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Related Info
Other Identifiers
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NCI-2013-00435
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC BRE 1277
Identifier Type: -
Identifier Source: org_study_id
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