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Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer

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ClinicalTrials.gov Identifier: NCT01938651
Recruitment Status : Terminated (funding ceased)
First Posted : September 10, 2013
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Yankeelov, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: high field strength magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Procedure: chemical exchange saturation transfer magnetic resonance imaging Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultra-High Field (7 Tesla) MRI/MRS Evaluation of Breast Cancer
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Procedure: high field strength magnetic resonance imaging
Undergo 7T MRI
Other Name: high field strength MRI

Procedure: magnetic resonance spectroscopic imaging
Undergo 31P MRS
Other Names:
  • 1H-nuclear magnetic resonance spectroscopic imaging
  • Proton Magnetic Resonance Spectroscopic Imaging

Procedure: chemical exchange saturation transfer magnetic resonance imaging
Undergo CEST-MRI
Other Name: CEST MRI

Procedure: diffusion-weighted magnetic resonance imaging
Undergo DW-MRI
Other Name: diffusion-weighted MRI

Procedure: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Other Name: DCE-MRI




Primary Outcome Measures :
  1. Sensitivity and specificity [ Time Frame: At time of imaging procedure ]
    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.


Secondary Outcome Measures :
  1. Pathological disease status [ Time Frame: At time of imaging procedure ]
    A generalized linear mixed models analysis of variance with a logit link will be used to predict pathological disease status from MRI and MRS parameters.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938651


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas Yankeelov Vanderbilt-Ingram Cancer Center

Additional Information:
Responsible Party: 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;, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01938651     History of Changes
Other Study ID Numbers: VICC BRE 1277
NCI-2013-00435 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

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