DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Baylor Research Institute
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Updated on 5 August 2020
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mammogram
ki-67
breast imaging reporting and data system

Summary

1.1. Primary Objectives

  • To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
  • We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis.
  • Once we validate the use of DWIBS-MRI ADC values to determine malignancy, can we establish an ADC threshold value to decrease the number of false positive biopsies that are performed while still maintaining a zero false negative rate?
  • This study will also assess the correlation between ADC values and the Ki-67 proliferative index of malignant lesions.

Details
Condition Breast Cancer, Breast Cancer
Age 30years - 100years
Clinical Study IdentifierNCT04491864
SponsorBaylor Research Institute
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'A patient will be eligible for inclusion in this study if she meets all of the'
b'following criteria:'
b'>30 years of age'
b'Genetic Female'
b'Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater'
b'than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging.'

Exclusion Criteria

b'A patient is ineligible for inclusion in this study if she meets any of the following'
b'criteria:'
b'Prior biopsy of suspicious lesion'
b'Breast implants'
b'Prior history of breast cancer'
b'Patient has a pacemaker'
b'Contraindications to use of MRI imaging (metal implants, etc.)'
b'Woman pregnant or lactating'
b'Calcifications as only findings present for a suspicious lesion'
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