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

• Conditions: Breast Cancer

• Registration Number: NCT04491864
• Lead Sponsor: Baylor Research Institute

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29
• Primary Completion: 2024-03-11
• Study Completion: 2024-03-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Baylor Scott & White Research Insitute; 🇺🇸 Dallas, Texas, United States