<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/NCT03750240</url>
  </required_header>
  <id_info>
    <org_study_id>17-00269</org_study_id>
    <nct_id>NCT03750240</nct_id>
  </id_info>
  <brief_title>Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy</brief_title>
  <official_title>Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before&#xD;
      surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive&#xD;
      disease, and guide additional therapies for patients with inadequate response, if detected&#xD;
      early. Investigators propose to develop a sodium breast MRI technique that will allow to&#xD;
      assess the early metabolic response of breast cancer to NACT, occurring before late&#xD;
      structural changes can be detected with standard MRI.&#xD;
&#xD;
      This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative&#xD;
      breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3&#xD;
      months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC&#xD;
      treatment (2 months); after complete NACT (5 months, pre-surgery).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    technical difficulties for scans on the research MRI system&#xD;
  </why_stopped>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">June 24, 2021</completion_date>
  <primary_completion_date type="Actual">June 24, 2021</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>Change in Tumor Size</measure>
    <time_frame>Baseline, 2 Years</time_frame>
    <description>Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Sodium Concentration (TSC)</measure>
    <time_frame>Baseline</time_frame>
    <description>TSC was directly measured from 23Na images using a phantom calibration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracellular Sodium Concentration (CIC)</measure>
    <time_frame>Baseline</time_frame>
    <description>CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Triple Negative Breast Cancer Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>scanned 4 times to assess breast cancer response to NACT with the proposed method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sodium (Na) Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Two Na data will be acquired:&#xD;
FLORET without Inversion Recovery (IR), and&#xD;
FLORET with IR</description>
    <arm_group_label>Triple Negative Breast Cancer Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dynamic Contrast- Enhanced (DCE) MRI</intervention_name>
    <description>DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data</description>
    <arm_group_label>Triple Negative Breast Cancer Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with no sign of breast cancer as controls&#xD;
&#xD;
          -  Non-pregnant and non-lactating&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants&#xD;
             that are not compatible with an MRI machine, claustrophobia etc.)&#xD;
&#xD;
          -  Medical condition such as uncontrolled infection (including HIV), uncontrolled&#xD;
             diabetes mellitus or cardiac disease which, in the opinion of the treating physician,&#xD;
             would make this protocol unreasonably hazardous for the patient.&#xD;
&#xD;
          -  Pregnant or lactating women, women using hormonal treatment in the 6 months prior to&#xD;
             the study.&#xD;
&#xD;
          -  Women with history of breast disease, previous breast surgery, or breast implants.&#xD;
&#xD;
          -  Patients with a currently active second malignancy other than non-melanoma skin&#xD;
             cancers. Patients are not considered to have a currently active malignancy if they&#xD;
             have completed therapy and are free of disease for 3 years.&#xD;
&#xD;
          -  Psychiatric illness or other conditions and circumstances which could prevent the&#xD;
             patient from being compliant with the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume Madelin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <results_first_submitted>August 1, 2022</results_first_submitted>
  <results_first_submitted_qc>August 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2022</results_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03750240/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Triple Negative Breast Cancer Patients</title>
          <description>scanned 4 times to assess breast cancer response to NACT with the proposed method.&#xD;
Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:&#xD;
FLORET without Inversion Recovery (IR), and&#xD;
FLORET with IR&#xD;
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Technical Difficulties</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Triple Negative Breast Cancer Patients</title>
          <description>scanned 4 times to assess breast cancer response to NACT with the proposed method.&#xD;
Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:&#xD;
FLORET without Inversion Recovery (IR), and&#xD;
FLORET with IR&#xD;
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.5" lower_limit="51" upper_limit="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Tumor Size</title>
        <description>Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.</description>
        <time_frame>Baseline, 2 Years</time_frame>
        <population>The study was terminated due to technical difficulties; therefore, no follow-ups during or after therapy were performed with only scans at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Triple Negative Breast Cancer Patients</title>
            <description>scanned 4 times to assess breast cancer response to NACT with the proposed method.&#xD;
Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:&#xD;
FLORET without Inversion Recovery (IR), and&#xD;
FLORET with IR&#xD;
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tumor Size</title>
          <description>Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.</description>
          <population>The study was terminated due to technical difficulties; therefore, no follow-ups during or after therapy were performed with only scans at baseline</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Sodium Concentration (TSC)</title>
        <description>TSC was directly measured from 23Na images using a phantom calibration</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Triple Negative Breast Cancer Patients</title>
            <description>scanned 4 times to assess breast cancer response to NACT with the proposed method.&#xD;
Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:&#xD;
FLORET without Inversion Recovery (IR), and&#xD;
FLORET with IR&#xD;
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data</description>
          </group>
        </group_list>
        <measure>
          <title>Total Sodium Concentration (TSC)</title>
          <description>TSC was directly measured from 23Na images using a phantom calibration</description>
          <units>mM</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participant 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.2" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intracellular Sodium Concentration (CIC)</title>
        <description>CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Triple Negative Breast Cancer Patients</title>
            <description>scanned 4 times to assess breast cancer response to NACT with the proposed method.&#xD;
Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:&#xD;
FLORET without Inversion Recovery (IR), and&#xD;
FLORET with IR&#xD;
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data</description>
          </group>
        </group_list>
        <measure>
          <title>Intracellular Sodium Concentration (CIC)</title>
          <description>CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat</description>
          <units>mM</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participant 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.6" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Triple Negative Breast Cancer Patients</title>
          <description>scanned 4 times to assess breast cancer response to NACT with the proposed method.&#xD;
Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:&#xD;
FLORET without Inversion Recovery (IR), and&#xD;
FLORET with IR&#xD;
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Guillaume Madelin, PhD</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>(212) 263-3343</phone>
      <email>guillaume.madelin@nyulangone.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03750240
org study id: 17-00269
nct id: NCT03750240
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before
      surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive
      disease, and guide additional therapies for patients with inadequate response, if detected
      early. Investigators propose to develop a sodium breast MRI technique that will allow to
      assess the early metabolic response of breast cancer to NACT, occurring before late
      structural changes can be detected with standard MRI.

      This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative
      breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3
      months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC
      treatment (2 months); after complete NACT (5 months, pre-surgery).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in Tumor Size
time frame: Baseline, 2 Years
description: Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
measure: Total Sodium Concentration (TSC)
time frame: Baseline
description: TSC was directly measured from 23Na images using a phantom calibration
measure: Intracellular Sodium Concentration (CIC)
time frame: Baseline
description: CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat
arm group label: Triple Negative Breast Cancer Patients
arm group type: Experimental
description: scanned 4 times to assess breast cancer response to NACT with the proposed method.
intervention type: Diagnostic Test
intervention name: Sodium (Na) Magnetic Resonance Imaging (MRI)
description: Two Na data will be acquired:
FLORET without Inversion Recovery (IR), and
FLORET with IR
arm group label: Triple Negative Breast Cancer Patients
intervention type: Diagnostic Test
intervention name: Dynamic Contrast- Enhanced (DCE) MRI
description: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
arm group label: Triple Negative Breast Cancer Patients
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Guillaume Madelin, PhD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 