<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/NCT03295695</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-19220</org_study_id>
    <nct_id>NCT03295695</nct_id>
  </id_info>
  <brief_title>PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient</brief_title>
  <official_title>Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single arm, phase 0 study to evaluate the safety and efficacy of PET-CT scans with&#xD;
      FDG-labeled RBC in patients with breast cancer.&#xD;
&#xD;
      Cardiac ejection fraction can be calculated and monitored in breast cancer patients during&#xD;
      chemotherapy using a FDG-RBC PET-CT scan. The purpose of this study is to determine if&#xD;
      calculated cardiac ejection fraction shows high concordance with results from&#xD;
      echocardiography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    closure of radiolaboratory&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Ejection Fraction (EF)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Calculated cardiac ejection fraction (EF) with a low radiation dose FDG-RBC PET-computed tomography (CT) scan before and after neoadjuvant chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordance Between FDG-RBC PET-CT and Echocardiogram</measure>
    <time_frame>Pre-treatment and Post-treatment, up to 12 months</time_frame>
    <description>The concordance will be estimated by the use of Lin's method49 along with 95% confidence interval.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Breast Cancer, Female</condition>
  <condition>Breast Cancer, Male</condition>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Cardiac Imaging - All Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study agent: 2-deoxy-2-[18F]fluoro-D-glucose (FDG). Fluoro-D-glucose-positron Emission Tomography: Participants will undergo a PET-CT scan with Fluoro-D-glucose-labeled (FDG-labeled) red blood cells (RBCs) within 2 weeks of obtaining an echocardiogram prior to start of chemotherapy. A repeat FDG-RBC PET-CT scan will be completed within two weeks of obtaining their follow-up echocardiogram to determine post-therapy cardiac ejection fraction. If the participant has an echocardiogram obtained prior to completion of chemotherapy, an attempt will be made to obtain a FDG-RBC PET-CT scan within two weeks of the echocardiogram.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fluoro-D-glucose-positron Emission Tomography</intervention_name>
    <description>2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET): within 2 weeks of obtaining first echocardiogram; within two weeks of obtaining follow-up echocardiogram.</description>
    <arm_group_label>Cardiac Imaging - All Participants</arm_group_label>
    <other_name>FDG-RBC PET-CT scan</other_name>
    <other_name>Cardiac blood pool imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>2-deoxy-2-[18F]fluoro-D-glucose (FDG)</intervention_name>
    <description>2-deoxy-2-[18F]fluoro-D-glucose (FDG) labeled autologous human erythrocytes (RBCs): Approximately 10 mls of packed human erythrocytes are collected from the patient and labeled with ≈5-10 milliCuries of commercially available United States Pharmacopeia (USP)-grade FDG (≈5-10 picograms FDG) (Vendor: Cardinal Health) under sterile conditions in a Good Manufacturing Practice (GMP)-certified laboratory.&#xD;
Synthesized RBCs: The cell suspension is manually infused via syringe through an indwelling peripheral venous catheter over the course of 1 minute, using an infusion method approved by the Moffitt Cancer Center (MCC) radiation safety officer.</description>
    <arm_group_label>Cardiac Imaging - All Participants</arm_group_label>
    <other_name>FDG-labeled RBCs</other_name>
    <other_name>18F-fluorodeoxyglucose (FDG)-labeled human erythrocytes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiogram</intervention_name>
    <description>Echocardiogram: prior to start of chemotherapy; post-treatment regimen.</description>
    <arm_group_label>Cardiac Imaging - All Participants</arm_group_label>
    <other_name>Echocardiography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have histologically confirmed breast cancer and be scheduled for&#xD;
             neoadjuvant Trastuzumab- or anthracycline-based chemotherapy.&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky &gt;60%).&#xD;
&#xD;
          -  Must be able to complete an informed consent process.&#xD;
&#xD;
          -  Must have normal organ and marrow function: leukocytes &gt;3,000/μL; absolute neutrophil&#xD;
             count &gt;1,500/μL; platelets &gt;100,000/μL; total bilirubin within normal institutional&#xD;
             limits; aspartate aminotransferase (AST)[SGOT] / alanine aminotransferase (ALT)[SGPT]:&#xD;
             less than 2.5 X institutional upper limit of normal; Creatinine within normal&#xD;
             institutional limits - OR - creatinine clearance&gt;60 mL/min/1.73 m^2 for patients with&#xD;
             creatinine level above institutional normal.&#xD;
&#xD;
          -  Echocardiogram results should be of sufficiently suitable quality (adequate acoustic&#xD;
             window access) to provide a reliable ejection fraction range calculation. The cardiac&#xD;
             ejection fraction on the pre-treatment echocardiogram should be 50% or higher.&#xD;
&#xD;
          -  Participants should be naïve to Trastuzumab or anthracycline chemotherapy prior to&#xD;
             enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of invasive breast cancer and treatment with anthracycline chemotherapy.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to FDG.&#xD;
&#xD;
          -  Known symptomatic coagulopathies, bleeding diathesis, hemoglobinopathies, or hemolytic&#xD;
             anemia.&#xD;
&#xD;
          -  Participants should have no clinically significant heart disease such as congestive&#xD;
             heart failure. Participants should not have other significant structural heart disease&#xD;
             by echocardiogram, or cardiac dysrhythmia on standard of care electrocardiogram that&#xD;
             may adversely affect the cardiac imaging results obtained with FDG-RBC PET-CT imaging.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Women who are pregnant.&#xD;
&#xD;
          -  Found to have a cardiac ejection fraction less than 50% on the pre-treatment&#xD;
             echocardiogram.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung Choi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://moffitt.org/clinical-trials-research/</url>
    <description>Moffitt Cancer Center Clinical Trials website</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>December 3, 2020</last_update_submitted>
  <last_update_submitted_qc>December 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chemotherapy induced cardiotoxicity</keyword>
  <keyword>Tumor blood perfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms, Male</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>
  <!-- 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/NCT03295695
org study id: MCC-19220
nct id: NCT03295695
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single arm, phase 0 study to evaluate the safety and efficacy of PET-CT scans with
      FDG-labeled RBC in patients with breast cancer.

      Cardiac ejection fraction can be calculated and monitored in breast cancer patients during
      chemotherapy using a FDG-RBC PET-CT scan. The purpose of this study is to determine if
      calculated cardiac ejection fraction shows high concordance with results from
      echocardiography.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Cardiac Ejection Fraction (EF)
time frame: Up to 12 months
description: Calculated cardiac ejection fraction (EF) with a low radiation dose FDG-RBC PET-computed tomography (CT) scan before and after neoadjuvant chemotherapy.
measure: Concordance Between FDG-RBC PET-CT and Echocardiogram
time frame: Pre-treatment and Post-treatment, up to 12 months
description: The concordance will be estimated by the use of Lin's method49 along with 95% confidence interval.
arm group label: Cardiac Imaging - All Participants
arm group type: Experimental
description: Study agent: 2-deoxy-2-[18F]fluoro-D-glucose (FDG). Fluoro-D-glucose-positron Emission Tomography: Participants will undergo a PET-CT scan with Fluoro-D-glucose-labeled (FDG-labeled) red blood cells (RBCs) within 2 weeks of obtaining an echocardiogram prior to start of chemotherapy. A repeat FDG-RBC PET-CT scan will be completed within two weeks of obtaining their follow-up echocardiogram to determine post-therapy cardiac ejection fraction. If the participant has an echocardiogram obtained prior to completion of chemotherapy, an attempt will be made to obtain a FDG-RBC PET-CT scan within two weeks of the echocardiogram.
intervention type: Diagnostic Test
intervention name: Fluoro-D-glucose-positron Emission Tomography
description: 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET): within 2 weeks of obtaining first echocardiogram; within two weeks of obtaining follow-up echocardiogram.
arm group label: Cardiac Imaging - All Participants
other name: FDG-RBC PET-CT scan
other name: Cardiac blood pool imaging
intervention type: Biological
intervention name: 2-deoxy-2-[18F]fluoro-D-glucose (FDG)
description: 2-deoxy-2-[18F]fluoro-D-glucose (FDG) labeled autologous human erythrocytes (RBCs): Approximately 10 mls of packed human erythrocytes are collected from the patient and labeled with ≈5-10 milliCuries of commercially available United States Pharmacopeia (USP)-grade FDG (≈5-10 picograms FDG) (Vendor: Cardinal Health) under sterile conditions in a Good Manufacturing Practice (GMP)-certified laboratory.
Synthesized RBCs: The cell suspension is manually infused via syringe through an indwelling peripheral venous catheter over the course of 1 minute, using an infusion method approved by the Moffitt Cancer Center (MCC) radiation safety officer.
arm group label: Cardiac Imaging - All Participants
other name: FDG-labeled RBCs
other name: 18F-fluorodeoxyglucose (FDG)-labeled human erythrocytes
intervention type: Diagnostic Test
intervention name: Echocardiogram
description: Echocardiogram: prior to start of chemotherapy; post-treatment regimen.
arm group label: Cardiac Imaging - All Participants
other name: Echocardiography
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jung Choi, M.D.
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
country: United States
url: https://moffitt.org/clinical-trials-research/
description: Moffitt Cancer Center Clinical Trials website
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Neoplasms, Male
mesh term: Fluorodeoxyglucose F18