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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04491864
Study type Observational
Source Baylor Research Institute
Contact Mariana Hurutado, RN
Phone 214.820.7755
Email [email protected]
Status Recruiting
Phase
Start date March 11, 2019
Completion date March 11, 2024

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