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Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high field strength magnetic resonance imaging
magnetic resonance spectroscopic imaging
chemical exchange saturation transfer magnetic resonance imaging
diffusion-weighted magnetic resonance imaging
dynamic contrast-enhanced magnetic resonance imaging
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (7T ultra high-field MRI/MRS)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pathological disease status
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.

Full Information

First Posted
September 4, 2013
Last Updated
August 2, 2016
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01938651
Brief Title
Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer
Official Title
Ultra-High Field (7 Tesla) MRI/MRS Evaluation of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
funding ceased
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (7T ultra high-field MRI/MRS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
high field strength magnetic resonance imaging
Other Intervention Name(s)
high field strength MRI
Intervention Description
Undergo 7T MRI
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Other Intervention Name(s)
1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging
Intervention Description
Undergo 31P MRS
Intervention Type
Procedure
Intervention Name(s)
chemical exchange saturation transfer magnetic resonance imaging
Other Intervention Name(s)
CEST MRI
Intervention Description
Undergo CEST-MRI
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Undergo DW-MRI
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Other Intervention Name(s)
DCE-MRI
Intervention Description
Undergo DCE-MRI
Primary Outcome Measure Information:
Title
Sensitivity and specificity
Description
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.
Time Frame
At time of imaging procedure
Secondary Outcome Measure Information:
Title
Pathological disease status
Description
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.
Time Frame
At time of imaging procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Yankeelov
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.vicc.org/ct/
Description
Related Info

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Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer

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