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

NCT04491864 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2026-01-26

No results posted yet for this study

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

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491864 on ClinicalTrials.gov