<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04491864</url>
  </required_header>
  <id_info>
    <org_study_id>018-781</org_study_id>
    <nct_id>NCT04491864</nct_id>
  </id_info>
  <brief_title>DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation</brief_title>
  <acronym>DWIBS</acronym>
  <official_title>DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor Research Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1.1. Primary Objectives&#xD;
&#xD;
        -  To determine if MRI DWIBS can accurately identify suspicious lesions previously&#xD;
           categorized on mammography and sonography as potentially malignant.&#xD;
&#xD;
        -  We will also validate whether DWIBS-MRI ADC values can be used to accurately&#xD;
           differentiate benign from malignant lesions. Additionally, because it is not known&#xD;
           whether tumor type or growth rate (Ki67 values) will affect our results, we will include&#xD;
           these parameters in our analysis.&#xD;
&#xD;
        -  Once we validate the use of DWIBS-MRI ADC values to determine malignancy, can we&#xD;
           establish an ADC threshold value to decrease the number of false positive biopsies that&#xD;
           are performed while still maintaining a zero false negative rate?&#xD;
&#xD;
        -  This study will also assess the correlation between ADC values and the Ki-67&#xD;
           proliferative index of malignant lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Anticipated">March 11, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 11, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MRI DWIBS Accuracy</measure>
    <time_frame>1 month</time_frame>
    <description>• To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validate DWIBS-MRI</measure>
    <time_frame>1 month</time_frame>
    <description>• 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.</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Genetically female patients age 30 and greater with suspicious BIRADS 4 or BIRADS 5 masses&#xD;
        and/or asymmetries on standard 2D/3D mammogram and ultrasound imaging&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A patient will be eligible for inclusion in this study if she meets all of the&#xD;
             following criteria:&#xD;
&#xD;
               1. &gt;30 years of age&#xD;
&#xD;
               2. Genetic Female&#xD;
&#xD;
               3. Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater&#xD;
                  than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A patient is ineligible for inclusion in this study if she meets any of the following&#xD;
             criteria:&#xD;
&#xD;
               1. Prior biopsy of suspicious lesion&#xD;
&#xD;
               2. Breast implants&#xD;
&#xD;
               3. Prior history of breast cancer&#xD;
&#xD;
               4. Patient has a pacemaker&#xD;
&#xD;
               5. Contraindications to use of MRI imaging (metal implants, etc.)&#xD;
&#xD;
               6. Woman pregnant or lactating&#xD;
&#xD;
               7. Calcifications as only findings present for a suspicious lesion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The study population under investigation are for participants who are genetically female.</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mariana Hurutado, RN</last_name>
    <phone>214.820.7755</phone>
    <email>Mariana.Hurutado@BSWHealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Research Insitute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariana Hurutado</last_name>
      <phone>214-820-7755</phone>
      <email>Mariana.Hurutado@BSWHealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor Research Institute</investigator_affiliation>
    <investigator_full_name>Sean Raj</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04491864
org study id: 018-781
nct id: NCT04491864
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: MRI DWIBS Accuracy
time frame: 1 month
description: • To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
measure: Validate DWIBS-MRI
time frame: 1 month
description: • 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: The study population under investigation are for participants who are genetically female.
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mariana Hurutado, RN
phone: 214.820.7755
email: Mariana.Hurutado@BSWHealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor Research Institute
investigator full name: Sean Raj
investigator title: Medical Doctor