Study Stopped
funding ceased
Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer
Ultra-High Field (7 Tesla) MRI/MRS Evaluation of Breast Cancer
2 other identifiers
interventional
3
1 country
1
Brief Summary
This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic procedures may be a more sensitive way to detect breast cancer.
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 Jan 2013
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
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedAugust 3, 2016
August 1, 2016
2.4 years
September 4, 2013
August 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity
Ninety-percent simultaneous confidence rectangles for sensitivity and specificity will be constructed at the 25th, 50th (median), and 75th percentiles of the model predicted probability of disease.
At time of imaging procedure
Secondary Outcomes (1)
Pathological disease status
At time of imaging procedure
Study Arms (1)
Diagnostic (7T ultra high-field MRI/MRS)
EXPERIMENTALPatients 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.
Interventions
Undergo 7T MRI
Undergo 31P MRS
Undergo CEST-MRI
Undergo DW-MRI
Undergo DCE-MRI
Eligibility Criteria
You may qualify if:
- Subjects must have signed an approved consent form
- 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.
You may not qualify if:
- Subjects who have distant metastases
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Yankeelov
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- 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;
Study Record Dates
First Submitted
September 4, 2013
First Posted
September 10, 2013
Study Start
January 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 3, 2016
Record last verified: 2016-08