<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/NCT03266562</url>
  </required_header>
  <id_info>
    <org_study_id>16-007764</org_study_id>
    <nct_id>NCT03266562</nct_id>
  </id_info>
  <brief_title>Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography</brief_title>
  <acronym>PEM-FES</acronym>
  <official_title>Assessment of the Heterogeneity of Estrogen Receptor Expression in Patients With Estrogen Receptor Positive Breast Cancer Using F-18 Fluoroestradiol and High Resolution Positron Emission Mammography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine the correlation between the distribution&#xD;
      of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of&#xD;
      the breast, and the distribution of cells stained ER+ within the tumor by&#xD;
      immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to&#xD;
      determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as&#xD;
      imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the&#xD;
      tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study will recruit up to 20 patients with newly diagnosed ER+ breast cancer who&#xD;
      have recently undergone or are scheduled to undergo a clinically-indicated breast MRI&#xD;
      examination and are scheduled for surgical excision of the breast cancer. All patients will&#xD;
      undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. As F-18 FES is not&#xD;
      an FDA-approved radiopharmaceutical, this FES study will be performed under an investigator&#xD;
      IND cross-referenced to the National Cancer Institute IND 79,005 for F-18 FES. A time&#xD;
      interval of 6-8 hours will be required between performance of the F-18 FDG study and the F-18&#xD;
      FES study. All patients will have the 2 PEM studies within 30 business days of the clinically&#xD;
      indicated MRI. See Study Schema shown below. Subjects must meet the following eligibility&#xD;
      criteria:&#xD;
&#xD;
        1. Postmenopausal women, as defined by a. Lack of menstrual periods for ≥ 12 months b. For&#xD;
           women with prior hysterectomy and age &lt; 60, a serum FSH level within the postmenopausal&#xD;
           range&#xD;
&#xD;
        2. Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP&#xD;
           guidelines (staining in ≥ 1% of cells by immunohistochemistry)&#xD;
&#xD;
        3. Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast&#xD;
           MRI examination&#xD;
&#xD;
        4. Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or&#xD;
           MRI.&#xD;
&#xD;
        5. Planned surgical excision of the breast cancer at Mayo Clinic, Rochester&#xD;
&#xD;
      Study participants will be consented prior to undergoing the PEM studies. The order in which&#xD;
      the PEM and MRI studies are performed will NOT be randomized, and will be dictated by patient&#xD;
      schedule. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess&#xD;
      the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER&#xD;
      expression in the tumor will be determined by immunohistochemistry on the pathologic tissue&#xD;
      and findings will then be correlated with the ratio of activity in the co-registered images&#xD;
      of F-18 FES and F-18 FDG. An integrated interpretation of the MRI and PEM images will be&#xD;
      performed to match lesions seen on the three scans and will be made available to the ordering&#xD;
      physician and surgeon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    unable to recruit patients due to competing studies&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>correlation of FES and estrogen receptors</measure>
    <time_frame>1 year</time_frame>
    <description>The primary objective of this study is to determine the correlation between F-18 FES uptake on PEM, and distribution of ER+ tissue on pathology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>correlation of FES and FDG in breast tumors</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>FES vs FDG</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>F-18 FES</intervention_name>
    <description>Evaluate uptake of F-18 FES in breast tissue</description>
    <arm_group_label>FES vs FDG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>F-18 FDG</intervention_name>
    <description>Evaluate uptake of F-18 FDG in breast tissue</description>
    <arm_group_label>FES vs FDG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible patients will be offered enrollment if the time interval between initial diagnosis&#xD;
        and surgery allows for performance of the PEM studies with both F18 FDG and F-18 FES, and&#xD;
        they meet the following criteria:&#xD;
&#xD;
          -  Postmenopausal women, as defined by&#xD;
&#xD;
               -  Lack of menstrual periods for ≥ 12 months&#xD;
&#xD;
               -  For women with prior hysterectomy and age &lt; 60, a serum FSH level within the&#xD;
                  postmenopausal range&#xD;
&#xD;
          -  Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP&#xD;
             guidelines (staining in ≥ 1% of cells by immunohistochemistry)&#xD;
&#xD;
          -  Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced&#xD;
             breast MRI examination&#xD;
&#xD;
          -  Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound,&#xD;
             or MRI.&#xD;
&#xD;
          -  Planned surgical excision of the breast cancer at Mayo Clinic, Rochester&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients are excluded if they meet any of the following criteria:&#xD;
&#xD;
          -  Premenopausal&#xD;
&#xD;
          -  Unable to undergo PEM scanning (weight limit of 300 lbs. on PEM system or inability to&#xD;
             lie prone for 30 minutes)&#xD;
&#xD;
          -  Total serum bilirubin &gt; 1.5 x upper limit of normal (abnormal hepatic metabolism may&#xD;
             interfere with FES hepatic excretion),&#xD;
&#xD;
          -  Serum creatinine &gt; 1.5 x upper limit of normal&#xD;
&#xD;
          -  Patients who have received, are currently receiving, or planning to receive&#xD;
             neoadjuvant systemic therapy prior to surgical excision&#xD;
&#xD;
          -  Patients who will undergo core needle biopsy of the breast or axilla between the&#xD;
             breast MRI and investigational PEM studies. NOTE: Axillary ultrasound with or without&#xD;
             fine needle aspiration of an axillary mass or lymph node is allowed.&#xD;
&#xD;
          -  Patients with breast implants?&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael K O'Connor, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Michael O'Connor</investigator_full_name>
    <investigator_title>consultant on medical physics</investigator_title>
  </responsible_party>
  <keyword>Positron Emission Mammography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03266562
org study id: 16-007764
nct id: NCT03266562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The primary objective of this study is to determine the correlation between the distribution
      of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of
      the breast, and the distribution of cells stained ER+ within the tumor by
      immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to
      determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as
      imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the
      tumor.
This pilot study will recruit up to 20 patients with newly diagnosed ER+ breast cancer who
      have recently undergone or are scheduled to undergo a clinically-indicated breast MRI
      examination and are scheduled for surgical excision of the breast cancer. All patients will
      undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. As F-18 FES is not
      an FDA-approved radiopharmaceutical, this FES study will be performed under an investigator
      IND cross-referenced to the National Cancer Institute IND 79,005 for F-18 FES. A time
      interval of 6-8 hours will be required between performance of the F-18 FDG study and the F-18
      FES study. All patients will have the 2 PEM studies within 30 business days of the clinically
      indicated MRI. See Study Schema shown below. Subjects must meet the following eligibility
      criteria:

        1. Postmenopausal women, as defined by a. Lack of menstrual periods for ≥ 12 months b. For
           women with prior hysterectomy and age < 60, a serum FSH level within the postmenopausal
           range

        2. Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP
           guidelines (staining in ≥ 1% of cells by immunohistochemistry)

        3. Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast
           MRI examination

        4. Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or
           MRI.

        5. Planned surgical excision of the breast cancer at Mayo Clinic, Rochester

      Study participants will be consented prior to undergoing the PEM studies. The order in which
      the PEM and MRI studies are performed will NOT be randomized, and will be dictated by patient
      schedule. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess
      the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER
      expression in the tumor will be determined by immunohistochemistry on the pathologic tissue
      and findings will then be correlated with the ratio of activity in the co-registered images
      of F-18 FES and F-18 FDG. An integrated interpretation of the MRI and PEM images will be
      performed to match lesions seen on the three scans and will be made available to the ordering
      physician and surgeon.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: correlation of FES and estrogen receptors
time frame: 1 year
description: The primary objective of this study is to determine the correlation between F-18 FES uptake on PEM, and distribution of ER+ tissue on pathology
measure: correlation of FES and FDG in breast tumors
time frame: 1 year
description: The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.
arm group label: FES vs FDG
arm group type: Other
description: All patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue
intervention type: Diagnostic Test
intervention name: F-18 FES
description: Evaluate uptake of F-18 FES in breast tissue
arm group label: FES vs FDG
intervention type: Diagnostic Test
intervention name: F-18 FDG
description: Evaluate uptake of F-18 FDG in breast tissue
arm group label: FES vs FDG
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Michael K O'Connor, Ph.D
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Michael O'Connor
investigator title: consultant on medical physics
mesh term: Breast Neoplasms
mesh term: Fluorodeoxyglucose F18
sharing ipd: No