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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04491864
Other study ID # 018-781
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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