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

Breast Cancer Clinical Trial

— DWIBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04491864
• Other study ID #: 018-781
• Status: Recruiting
• Start date: March 11, 2019
• Est. completion date: March 11, 2024

Study information

• Verified date: July 2020
• Source: Baylor Research Institute
• Contact: Mariana Hurutado, RN
• Phone: 214.820.7755
• Email: Mariana.Hurutado[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Baylor Scott & White Research Insitute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI DWIBS Accuracy	• To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.	1 month
Primary	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