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Clinical Trials/NCT02812589
NCT02812589
Completed
Not Applicable

Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)

University Health Network, Toronto1 site in 1 country267 target enrollmentApril 2016
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University Health Network, Toronto
Enrollment
267
Locations
1
Primary Endpoint
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
April 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female of any race, ethnicity and lifetime risk.
  • Eighteen years or older.
  • Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side.
  • Self-detected lump suspicious for breast cancer that it has not been biopsied yet.

Exclusion Criteria

  • Inability to understand the consent form
  • Pregnant or nursing
  • Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention
  • Physically unable to lie down on her belly for at least 10 minutes.
  • Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.

Outcomes

Primary Outcomes

Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates

Time Frame: 3 years

Study Sites (1)

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