<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/NCT04468867</url>
  </required_header>
  <id_info>
    <org_study_id>RD19/121361</org_study_id>
    <nct_id>NCT04468867</nct_id>
  </id_info>
  <brief_title>Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy</brief_title>
  <acronym>RABUS</acronym>
  <official_title>Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Leeds Teaching Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some women who have been diagnosed with a breast cancer will require chemotherapy as part of&#xD;
      their treatment. The chemotherapy can be given before breast surgery - neoadjuvant&#xD;
      chemotherapy or after breast surgery - adjuvant chemotherapy. Whether chemotherapy is given&#xD;
      before or after does not affect the clinical outcomes for the woman - ie there is no&#xD;
      disadvantage to the woman. Due to the fact that giving chemotherapy before has no&#xD;
      disadvantages, many of the oncologists like to give the chemotherapy before because they can&#xD;
      see if the breast cancer is responding. They are able to do this by using imaging. The best&#xD;
      imaging test is breast MRI. Ultrasound can be used but studies have shown that it is not as&#xD;
      good. However, whole breast ultrasound (ABUS) provides 3 dimensional information similar to&#xD;
      breast MRI and the purpose of our study is to see if ABUS performs similar to breast MRI in&#xD;
      being able to see if a tumour is responding to the chemotherapy. The breast MRI requires&#xD;
      women to lie facing down and takes about 20mins. It involves an injection of contrast called&#xD;
      gadolinium via a cannula. ABUS involves scanning the whole breast with the patient lying on&#xD;
      their back and takes 10mins. There is no injection of contrast. MRI is an expensive test and&#xD;
      often there is limited access to the scanner and so patients may have to wait for an&#xD;
      appointment. ABUS because it is an automated process for obtaining the images can be&#xD;
      performed in the breast unit in a timely manner without the issue of competing demands. All&#xD;
      women who agree to take part in the study will have both the breast MRI - standard or care&#xD;
      and the ABUS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 22, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumour size</measure>
    <time_frame>20 mins</time_frame>
    <description>Response will be assessed using RECIST criteria. Longest diameter response was scored based on the RECIST guidelines (PD&gt;20% increase, SD&lt;20% increase to&lt;30% decrease, PR&gt;30% decrease in longest diameter and CR if no tumour is visible).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Patient group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Automated whole breast ultrasound</intervention_name>
    <description>This will be performed by a band 6 radiographer and will be done at baseline, post 2 cycles of chemotherapy and end of treatment chemotherapy</description>
    <arm_group_label>Patient group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breast MRI</intervention_name>
    <description>This will be performed by band 6 or 7 radiographer with MRI training</description>
    <arm_group_label>Patient group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All female participants eligible for neoadjuvant chemotherapy and planning surgical&#xD;
             treatment&#xD;
&#xD;
          2. Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. All female particpants having neoadjuvant chemotherapy as palliative treatment with no&#xD;
             surgery planned&#xD;
&#xD;
          2. Unable to provide informed consent&#xD;
&#xD;
          3. Unable to have breast MRI scan due to clautrophobia or allergy to gadolineum&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nisha Sharma, mMBChB, MRCP (UK), FRCR</last_name>
    <phone>0113 2063798</phone>
    <email>nisha.sharma2@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nisha Sharma, mMBChB, MRCP (UK), FRCR</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04468867
org study id: RD19/121361
nct id: NCT04468867
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Some women who have been diagnosed with a breast cancer will require chemotherapy as part of
      their treatment. The chemotherapy can be given before breast surgery - neoadjuvant
      chemotherapy or after breast surgery - adjuvant chemotherapy. Whether chemotherapy is given
      before or after does not affect the clinical outcomes for the woman - ie there is no
      disadvantage to the woman. Due to the fact that giving chemotherapy before has no
      disadvantages, many of the oncologists like to give the chemotherapy before because they can
      see if the breast cancer is responding. They are able to do this by using imaging. The best
      imaging test is breast MRI. Ultrasound can be used but studies have shown that it is not as
      good. However, whole breast ultrasound (ABUS) provides 3 dimensional information similar to
      breast MRI and the purpose of our study is to see if ABUS performs similar to breast MRI in
      being able to see if a tumour is responding to the chemotherapy. The breast MRI requires
      women to lie facing down and takes about 20mins. It involves an injection of contrast called
      gadolinium via a cannula. ABUS involves scanning the whole breast with the patient lying on
      their back and takes 10mins. There is no injection of contrast. MRI is an expensive test and
      often there is limited access to the scanner and so patients may have to wait for an
      appointment. ABUS because it is an automated process for obtaining the images can be
      performed in the breast unit in a timely manner without the issue of competing demands. All
      women who agree to take part in the study will have both the breast MRI - standard or care
      and the ABUS.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tumour size
time frame: 20 mins
description: Response will be assessed using RECIST criteria. Longest diameter response was scored based on the RECIST guidelines (PD>20% increase, SD<20% increase to<30% decrease, PR>30% decrease in longest diameter and CR if no tumour is visible).
arm group label: Patient group
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Automated whole breast ultrasound
description: This will be performed by a band 6 radiographer and will be done at baseline, post 2 cycles of chemotherapy and end of treatment chemotherapy
arm group label: Patient group
intervention type: Diagnostic Test
intervention name: Breast MRI
description: This will be performed by band 6 or 7 radiographer with MRI training
arm group label: Patient group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Nisha Sharma, mMBChB, MRCP (UK), FRCR
phone: 0113 2063798
email: nisha.sharma2@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor