<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/NCT01672021</url>
  </required_header>
  <id_info>
    <org_study_id>12-02243</org_study_id>
    <nct_id>NCT01672021</nct_id>
  </id_info>
  <brief_title>Initial Assessment of 18FDG-PET/MRIin Determining the Extent of Systemic Disease in Breast Cancer Patients</brief_title>
  <official_title>Initial Assessment of 18FDG-PET/MRI in Determining the Extent of Systemic Disease in Breast Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Because MRI can provide increased brain and liver lesion detection as compared with CT, the&#xD;
      investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion&#xD;
      detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation&#xD;
      dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an initial assessment of the ability of 18FDG-PET/MR imaging to detect systemic&#xD;
      disease in breast cancer patients as compared with conventional 18FDG-PET/CT.&#xD;
&#xD;
      Rationale: Accurate assessment of the extent systemic disease in breast cancer patients both&#xD;
      initially and throughout treatment and surveillance comprises the basis for clinical care&#xD;
      including surgical planning, radiation and drug selection. Shortcomings in FDG-PET/CT, a&#xD;
      common current method of disease detection and surveillance, include decreased sensitivity in&#xD;
      brain, liver and bone and a relatively high radiation dose, which could cause up to 5 new&#xD;
      cancers per 1,000 patients (young American women) per scan. Initial studies assessing whole&#xD;
      body MRI, a technique which involves no radiation, in the staging of breast cancer patients&#xD;
      show promise, but can suffer from decreased ability to detect nodal disease and from&#xD;
      detection of false positive lesions. Manual fusion of PET and MRI data in bowel and breast&#xD;
      organ systems has been shown to decrease false positive lesions as compared with MRI alone.&#xD;
      In the past year, molecular MRI imaging machines which combine PET and MRI imaging have&#xD;
      become available for research purposes.&#xD;
&#xD;
      Hypothesis 1: We therefore hypothesize that FDG-PET/MRI will provide concordant or improved&#xD;
      lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased&#xD;
      radiation dose.&#xD;
&#xD;
      Hypothesis 2: In addition, the simultaneously acquired PET and MRI data allows for analysis&#xD;
      of local tumor characteristics including perfusion, cellularity and glucose metabolism. In&#xD;
      the subgroup of patients with an index breast cancer, we hypothesize that these local tumor&#xD;
      metrics correlate with number and sites of systemic lesions.&#xD;
&#xD;
      Methods: All newly diagnosed breast cancer patients who are undergoing imaging evaluation for&#xD;
      initial extent of disease or disease surveillance at NYU Cancer Center and Bellevue hospital&#xD;
      are candidates for study in this protocol. Patients will be invited for follow-up FDG-PET/MRI&#xD;
      imaging at any time they are undergoing FDG-PET/CT as part of their clinical care.&#xD;
&#xD;
      Subjects are undergoing FDG-PET/CT at the Cancer Center on 34th St and Lexington Avenue as&#xD;
      part of routine care and will be transferred directly to the 38th St. facility by car in a&#xD;
      timely manner so that an additional dose of 18-FDG labeled glucose will be unnecessary for&#xD;
      the experimental FDG-PET/MRI.&#xD;
&#xD;
      FDG-PET/MRI will be performed and is estimated to 45-60 minutes of scanning time. The patient&#xD;
      will then be free to leave the department. Data will be transferred to a workstation and&#xD;
      interpreted by two independent radiologists. Size and location of each lesion will be&#xD;
      recorded in a confidentiality protected spreadsheet for each component of the scan and the&#xD;
      lesion load will be defined by the union of all detected lesions from all three components&#xD;
      (DCE-MRI, diffusion-weighted imaging (DWI), FDG-PET). Data will be compared on a per lesion,&#xD;
      per organ system and per patient basis with the patient's routine FDG-PET/CT for presence of&#xD;
      metastatic disease and size and number of metastatic lesions.&#xD;
&#xD;
      In the case where PET/MRI demonstrates metastatic disease not seen on routine modalities, the&#xD;
      referring physician will be alerted. Additional dedicated radiologic studies and biopsy may&#xD;
      be recommended and performed at the discretion of the referring physician.&#xD;
&#xD;
      Results: Results of FDG-PET/MRI and FDG-PET/CT findings will be reported in a descriptive&#xD;
      format together with related biopsy results and histopathologic correlation. An exact 95%&#xD;
      confidence interval will be derived for the true percentage of times the assessment of&#xD;
      disease state lesion, per organ system and per patient from FDG-PET/MRI will be concordant&#xD;
      with the assessments derived for the same patient using the FDG-PET/CT. In patients with an&#xD;
      index breast cancer, Pearson and Spearman rank correlations will be used to characterize the&#xD;
      association between local tumor metrics and metastatic burden and location.&#xD;
&#xD;
      Potential benefits: 1. Equal or improved ability to detect metastatic disease in breast&#xD;
      cancer patients at a decreased radiation dose. 2. An improved understanding of index tumor&#xD;
      metrics help stratify risk for metastatic disease based on the index tumor and enable&#xD;
      individually tailored surveillance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">October 5, 2021</completion_date>
  <primary_completion_date type="Actual">October 5, 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>Number of metastatic lesions seen on PET/MRI as compared with PET/CT</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient stage as imaged by PET/MRI as compared with PET/CT</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>PET/MRI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>PET/MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PET/MRI</intervention_name>
    <description>PET/MRI</description>
    <arm_group_label>PET/MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Any patient with a history or breast cancer undergoing PET/CT either for initial staging or&#xD;
        for disease surveillance&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients and patients with known contraindications for whole body MR imaging&#xD;
             (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from&#xD;
             the study. Patients will be screened with a questionnaire to be sure they have no&#xD;
             medical devices that could make the procedure unsafe. Patients with glomerular&#xD;
             filtration rate (GFR) &lt; 15 ml/min/1.73m2 or who are on dialysis will be excluded from&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Heacock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU School of Medicine</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>October 2021</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>MRI PET-CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01672021
org study id: 12-02243
nct id: NCT01672021
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Because MRI can provide increased brain and liver lesion detection as compared with CT, the
      investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion
      detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation
      dose.
This study is an initial assessment of the ability of 18FDG-PET/MR imaging to detect systemic
      disease in breast cancer patients as compared with conventional 18FDG-PET/CT.

      Rationale: Accurate assessment of the extent systemic disease in breast cancer patients both
      initially and throughout treatment and surveillance comprises the basis for clinical care
      including surgical planning, radiation and drug selection. Shortcomings in FDG-PET/CT, a
      common current method of disease detection and surveillance, include decreased sensitivity in
      brain, liver and bone and a relatively high radiation dose, which could cause up to 5 new
      cancers per 1,000 patients (young American women) per scan. Initial studies assessing whole
      body MRI, a technique which involves no radiation, in the staging of breast cancer patients
      show promise, but can suffer from decreased ability to detect nodal disease and from
      detection of false positive lesions. Manual fusion of PET and MRI data in bowel and breast
      organ systems has been shown to decrease false positive lesions as compared with MRI alone.
      In the past year, molecular MRI imaging machines which combine PET and MRI imaging have
      become available for research purposes.

      Hypothesis 1: We therefore hypothesize that FDG-PET/MRI will provide concordant or improved
      lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased
      radiation dose.

      Hypothesis 2: In addition, the simultaneously acquired PET and MRI data allows for analysis
      of local tumor characteristics including perfusion, cellularity and glucose metabolism. In
      the subgroup of patients with an index breast cancer, we hypothesize that these local tumor
      metrics correlate with number and sites of systemic lesions.

      Methods: All newly diagnosed breast cancer patients who are undergoing imaging evaluation for
      initial extent of disease or disease surveillance at NYU Cancer Center and Bellevue hospital
      are candidates for study in this protocol. Patients will be invited for follow-up FDG-PET/MRI
      imaging at any time they are undergoing FDG-PET/CT as part of their clinical care.

      Subjects are undergoing FDG-PET/CT at the Cancer Center on 34th St and Lexington Avenue as
      part of routine care and will be transferred directly to the 38th St. facility by car in a
      timely manner so that an additional dose of 18-FDG labeled glucose will be unnecessary for
      the experimental FDG-PET/MRI.

      FDG-PET/MRI will be performed and is estimated to 45-60 minutes of scanning time. The patient
      will then be free to leave the department. Data will be transferred to a workstation and
      interpreted by two independent radiologists. Size and location of each lesion will be
      recorded in a confidentiality protected spreadsheet for each component of the scan and the
      lesion load will be defined by the union of all detected lesions from all three components
      (DCE-MRI, diffusion-weighted imaging (DWI), FDG-PET). Data will be compared on a per lesion,
      per organ system and per patient basis with the patient's routine FDG-PET/CT for presence of
      metastatic disease and size and number of metastatic lesions.

      In the case where PET/MRI demonstrates metastatic disease not seen on routine modalities, the
      referring physician will be alerted. Additional dedicated radiologic studies and biopsy may
      be recommended and performed at the discretion of the referring physician.

      Results: Results of FDG-PET/MRI and FDG-PET/CT findings will be reported in a descriptive
      format together with related biopsy results and histopathologic correlation. An exact 95%
      confidence interval will be derived for the true percentage of times the assessment of
      disease state lesion, per organ system and per patient from FDG-PET/MRI will be concordant
      with the assessments derived for the same patient using the FDG-PET/CT. In patients with an
      index breast cancer, Pearson and Spearman rank correlations will be used to characterize the
      association between local tumor metrics and metastatic burden and location.

      Potential benefits: 1. Equal or improved ability to detect metastatic disease in breast
      cancer patients at a decreased radiation dose. 2. An improved understanding of index tumor
      metrics help stratify risk for metastatic disease based on the index tumor and enable
      individually tailored surveillance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of metastatic lesions seen on PET/MRI as compared with PET/CT
time frame: 1 year
measure: Patient stage as imaged by PET/MRI as compared with PET/CT
time frame: 1 year
arm group label: PET/MRI
arm group type: Other
description: PET/MRI
intervention type: Procedure
intervention name: PET/MRI
description: PET/MRI
arm group label: PET/MRI
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Laura Heacock, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms