NCT04491864

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Timeline

• Start date: 2019-03-11
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-07-29
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States