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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Research Insitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Genetically female patients age 30 and greater with suspicious BIRADS 4 or BIRADS 5 masses and/or asymmetries on standard 2D/3D mammogram and ultrasound imaging

Description

Inclusion Criteria:

• A patient will be eligible for inclusion in this study if she meets all of the following criteria:

  1. >30 years of age
  2. Genetic Female
  3. 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 Criteria:

• A patient is ineligible for inclusion in this study if she meets any of the following criteria:

  1. Prior biopsy of suspicious lesion
  2. Breast implants
  3. Prior history of breast cancer
  4. Patient has a pacemaker
  5. Contraindications to use of MRI imaging (metal implants, etc.)
  6. Woman pregnant or lactating
  7. Calcifications as only findings present for a suspicious lesion

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI DWIBS Accuracy	• To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.	1 month
Validate DWIBS-MRI	• 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.	1 month

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 018-781

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No