Status:
UNKNOWN
DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation
Lead Sponsor:
Baylor Research Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
30+ years
Brief 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 w...
Eligibility Criteria
Inclusion
- A patient will be eligible for inclusion in this study if she meets all of the following criteria:
- \>30 years of age
- Genetic Female
- Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging.
Exclusion
- A patient is ineligible for inclusion in this study if she meets any of the following criteria:
- Prior biopsy of suspicious lesion
- Breast implants
- Prior history of breast cancer
- Patient has a pacemaker
- Contraindications to use of MRI imaging (metal implants, etc.)
- Woman pregnant or lactating
- Calcifications as only findings present for a suspicious lesion
Key Trial Info
Start Date :
March 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 11 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04491864
Start Date
March 11 2019
End Date
March 11 2024
Last Update
July 29 2020
Active Locations (1)
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1
Baylor Scott & White Research Insitute
Dallas, Texas, United States, 75246