<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/NCT02244593</url>
  </required_header>
  <id_info>
    <org_study_id>OHSN-REB 20140103-01H</org_study_id>
    <nct_id>NCT02244593</nct_id>
  </id_info>
  <brief_title>FAST MRI Study in Breast Cancer Survivors</brief_title>
  <official_title>FAST MRI Study in Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for&#xD;
      detecting breast cancer however, MRI is not always reliable because it can indicate the&#xD;
      presence of cancer when in reality, there is none; this is called a 'false positive' result.&#xD;
      A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with&#xD;
      breast MRI. This study is being done to assess a new technique called FAST breast MRI. A FAST&#xD;
      breast MRI is different than a traditional breast MRI because it has much fewer sequences and&#xD;
      takes approximately 3 minutes for the scan. MRI sequences are combinations of magnetic pulses&#xD;
      that collect information about the tissues. There is no radiation associated with an MRI.&#xD;
&#xD;
      The purpose of this study is to determine the impact on patient health when a FAST breast MRI&#xD;
      is used as a screening technique in women with a personal history of cancer. It has been&#xD;
      shown that FAST breast MRI is similar to routine breast MRI in the detection of breast&#xD;
      cancer, but it has not been proven that FAST breast MRI will help women who have a personal&#xD;
      history for breast cancer. Currently, routine breast MRI is not part of the standard of care&#xD;
      in screening for breast cancer in women who have a prior personal history of breast cancer.&#xD;
      By evaluating FAST MRI the investigators are able to study the effects of this short MRI on&#xD;
      cancer detection in women with a personal history of breast cancer, and on the impact on&#xD;
      overall health. The investigators estimate that 300 participants will be enrolled in the&#xD;
      study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the&#xD;
      Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants&#xD;
      have had a history of breast carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Given the demand for breast MRI screening by breast cancer survivors and oncologists, we plan&#xD;
      to perform a randomized controlled trial in a select patient population of breast cancer&#xD;
      survivors who would not normally be eligible for breast MRI screening. This study will&#xD;
      determine whether using FAST MRI in addition to mammography will reduce anxiety in patients&#xD;
      compared to the current standard of care: mammography alone. If it turns out to reduce&#xD;
      anxiety, the next step would be to conduct a large-scale multi-centre randomized control&#xD;
      trial (RCT) to evaluate whether FAST MRI is more sensitive and whether the increased&#xD;
      sensitivity leads to improved clinical outcomes.&#xD;
&#xD;
      The purpose of our study is to determine the impact on patient anxiety of FAST Breast MRI as&#xD;
      a surveillance technique in women with a personal history of breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 25, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients with reduced anxiety as a result of having a FAST MRI</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numbers of recurrent tumors in each arm</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of tumors missed by mammography</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Mammography screening only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive their standard of care mammogram only. Participants in this arm will not receive the FAST MRI.&#xD;
Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FAST MRI and mammogram screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram. The intervention is the addition of the FAST Breast MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FAST MRI and mammography screening</intervention_name>
    <description>Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.</description>
    <arm_group_label>FAST MRI and mammogram screening</arm_group_label>
    <other_name>FAST MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English or French speaking female patients over the age of 18 years, with a personal&#xD;
             history of a diagnosis of breast carcinoma (including ductal carcinoma in situ (DCIS)&#xD;
             and invasive ductal or lobular carcinoma) within the past 10 years.&#xD;
&#xD;
          -  Patients must have completed treatment for their breast cancer.&#xD;
&#xD;
          -  Moderate risk for recurrence of breast cancer, defined as lifetime risk of breast&#xD;
             cancer greater than 12% (average risk) and less than 25% (high risk) as defined using&#xD;
             the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm&#xD;
             (BOADICEA) model (see Appendix A)&#xD;
&#xD;
          -  Patients who have undergone unilateral mastectomy or breast conservation surgery.&#xD;
&#xD;
          -  Normal renal function: estimated glomerular filtration rate (eGFR) &gt; 30 ml/min/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to undergo an MRI, due to either physical or mental issues (i.e.:&#xD;
             anxiety or severe claustrophobia). Also, patient with a known allergy to gadolinium,&#xD;
             or severe renal failure will be excluded.&#xD;
&#xD;
          -  Pregnant or breastfeeding patients.&#xD;
&#xD;
          -  Patients who have had a breast MRI within the last 6 months.&#xD;
&#xD;
          -  Patients already receiving high-risk breast MRI screening, such as the Ontario Breast&#xD;
             Screening Program (OBSP) high-risk program and the Women's Breast Health Center (WBHC)&#xD;
             high-risk program.&#xD;
&#xD;
          -  Patients who have undergone bilateral mastectomies.&#xD;
&#xD;
          -  Poor renal function: estimated glomerular filtration rate (eGFR) &lt; 30 ml/min/m2&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Seely, MD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 9L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ottawa Hospital Research Institute</investigator_affiliation>
    <investigator_full_name>Jean Seely</investigator_full_name>
    <investigator_title>Dr. Jean Seely</investigator_title>
  </responsible_party>
  <keyword>breast cancer survivors</keyword>
  <keyword>FAST MRI</keyword>
  <keyword>mammography screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Planning on submitting preliminary results to RSNA 2017 and full publication by Oct 2018.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>January 13, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02244593
org study id: OHSN-REB 20140103-01H
nct id: NCT02244593
lead sponsor: 
has dmc: No
Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for
      detecting breast cancer however, MRI is not always reliable because it can indicate the
      presence of cancer when in reality, there is none; this is called a 'false positive' result.
      A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with
      breast MRI. This study is being done to assess a new technique called FAST breast MRI. A FAST
      breast MRI is different than a traditional breast MRI because it has much fewer sequences and
      takes approximately 3 minutes for the scan. MRI sequences are combinations of magnetic pulses
      that collect information about the tissues. There is no radiation associated with an MRI.

      The purpose of this study is to determine the impact on patient health when a FAST breast MRI
      is used as a screening technique in women with a personal history of cancer. It has been
      shown that FAST breast MRI is similar to routine breast MRI in the detection of breast
      cancer, but it has not been proven that FAST breast MRI will help women who have a personal
      history for breast cancer. Currently, routine breast MRI is not part of the standard of care
      in screening for breast cancer in women who have a prior personal history of breast cancer.
      By evaluating FAST MRI the investigators are able to study the effects of this short MRI on
      cancer detection in women with a personal history of breast cancer, and on the impact on
      overall health. The investigators estimate that 300 participants will be enrolled in the
      study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the
      Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants
      have had a history of breast carcinoma.
Given the demand for breast MRI screening by breast cancer survivors and oncologists, we plan
      to perform a randomized controlled trial in a select patient population of breast cancer
      survivors who would not normally be eligible for breast MRI screening. This study will
      determine whether using FAST MRI in addition to mammography will reduce anxiety in patients
      compared to the current standard of care: mammography alone. If it turns out to reduce
      anxiety, the next step would be to conduct a large-scale multi-centre randomized control
      trial (RCT) to evaluate whether FAST MRI is more sensitive and whether the increased
      sensitivity leads to improved clinical outcomes.

      The purpose of our study is to determine the impact on patient anxiety of FAST Breast MRI as
      a surveillance technique in women with a personal history of breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The percentage of patients with reduced anxiety as a result of having a FAST MRI
time frame: up to 12 months
measure: Numbers of recurrent tumors in each arm
time frame: 12 months
measure: Number of tumors missed by mammography
time frame: 12 months
arm group label: Mammography screening only
arm group type: No Intervention
description: This group will receive their standard of care mammogram only. Participants in this arm will not receive the FAST MRI.
Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.
arm group label: FAST MRI and mammogram screening
arm group type: Experimental
description: Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram. The intervention is the addition of the FAST Breast MRI.
intervention type: Other
intervention name: FAST MRI and mammography screening
description: Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.
arm group label: FAST MRI and mammogram screening
other name: FAST MRI
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Seely, MD FRCPC
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Ottawa Hospital Research Institute
investigator full name: Jean Seely
investigator title: Dr. Jean Seely
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: Planning on submitting preliminary results to RSNA 2017 and full publication by Oct 2018.
submitted: January 13, 2023