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

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ClinicalTrials.gov Identifier: NCT04491864
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Sean Raj, Baylor Research Institute

Study Description
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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.

Condition or disease
Breast Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : March 11, 2024
Estimated Study Completion Date : March 11, 2024

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. MRI DWIBS Accuracy [ Time Frame: 1 month ]
    • To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.

  2. Validate DWIBS-MRI [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study population under investigation are for participants who are genetically female.
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491864


Contacts
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Contact: Mariana Hurutado, RN 214.820.7755 Mariana.Hurutado@BSWHealth.org

Locations
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United States, Texas
Baylor Scott & White Research Insitute Recruiting
Dallas, Texas, United States, 75246
Contact: Mariana Hurutado    214-820-7755    Mariana.Hurutado@BSWHealth.org   
Sponsors and Collaborators
Baylor Research Institute
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sean Raj, Medical Doctor, Baylor Research Institute
ClinicalTrials.gov Identifier: NCT04491864    
Other Study ID Numbers: 018-781
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No