<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/NCT02249520</url>
  </required_header>
  <id_info>
    <org_study_id>35521</org_study_id>
    <nct_id>NCT02249520</nct_id>
  </id_info>
  <brief_title>Calibration of MR and PET-MR Imaging Protocols at RIC</brief_title>
  <official_title>Calibration of MR and PET-MR Imaging Protocols at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens&#xD;
      Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner&#xD;
      and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical&#xD;
      Imaging Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR&#xD;
      is a FDA-approved standard clinical device (non-experimental) and will be used in accordance&#xD;
      with clearance and approval from the FDA. The Vida is a state-of-the-art FDA approved scanner&#xD;
      and will be clinically licensed within a short time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PET-MR Protocol on the Biograph mMR: This protocol requires the use of a radioisotope. To&#xD;
      avoid administering radioisotope solely for the purposes of this calibration, we will recruit&#xD;
      20 patients from the clinical population at the S. Mark Taper Foundation Imaging Center at&#xD;
      CSMC who are already receiving an isotope dose for their standard-of-care examination and are&#xD;
      willing to be scanned at the Research Imaging Core on the same day right after their clinical&#xD;
      exam. Subjects who are having a PET-MR after receiving FDG will have the same body part&#xD;
      scanned as they did for clinical testing.&#xD;
&#xD;
      MR-only Protocol on the Biograph mMR:To set up MR-only protocols, we will enroll 20&#xD;
      volunteers for MR-only on the mMR scanner. This is a standard MR scan with no isotope&#xD;
      involved. Those volunteers who are participating in the MR-only scan will have major body&#xD;
      parts and organs scanned as needed for calibration.&#xD;
&#xD;
      MR imaging on the Siemens Vida 3T scanner: applications training is taking place and we will&#xD;
      build clinical protocols in the future&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2040</completion_date>
  <primary_completion_date type="Anticipated">December 2040</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>composite of measures of organ uptake, maximum target-to-background ratio and maximum standard uptake value as standard with FDG PET for maximum image quality for all standard protocols.</measure>
    <time_frame>one day</time_frame>
    <description>The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. Results obtained from these tests will not be analyzed towards the end point of any study and will solely be used to finalize and calibrate the technical performance of the new scanner. All scans will be visually assessed for technique calibration.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cancer</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>PET-MR imaging on Biograph mMR scanner</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Research PET-MR imaging on Biograph mMR scanner will be conducted immediately following administration of FDG for clinically approved scan. No additional radioisotope will be administered for the research scan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MR-only imaging on Biograph mMR scanner</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will undergo research MR-only imaging on Biograph mMR scanner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MR imaging on the Siemens Vida 3T MR scanner</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will undergo research MR imaging on the Siemens MR scanner</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PET-MR imaging on Biograph mMR scanner</intervention_name>
    <description>Participants will undergo PET-MR imaging on the Biograph mMR scanner to evaluate the technical aspects of the total acquisition protocol directly post clinical administration of FDG, thus removing the requirement for additional radioisotope.</description>
    <arm_group_label>PET-MR imaging on Biograph mMR scanner</arm_group_label>
    <other_name>Siemens Biograph mMR</other_name>
    <other_name>molecular imaging</other_name>
    <other_name>PET-MR</other_name>
    <other_name>mMR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MR-only imaging on Biograph mMR scanner</intervention_name>
    <description>Participants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered.</description>
    <arm_group_label>MR-only imaging on Biograph mMR scanner</arm_group_label>
    <other_name>Siemens Biograph mMR</other_name>
    <other_name>PET-MR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MR imaging on the Siemens Vida 3T MR scanner</intervention_name>
    <description>Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner</description>
    <arm_group_label>MR imaging on the Siemens Vida 3T MR scanner</arm_group_label>
    <other_name>MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  For MR-PET calibration: Outpatient undergoing standard-of-care 18FDG-PET at S. Mark&#xD;
             Taper Foundation Imaging Center at CSMC&#xD;
&#xD;
          -  For MR-only calibration: Volunteers who are responding to approved advertising to&#xD;
             volunteer at the BIRI Research Imaging Core for research MR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any contraindications to MR imaging.&#xD;
&#xD;
          -  Any contraindication to MRI, including metallic implants (valve replacement,&#xD;
             pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial&#xD;
             clips, metallic fragments in eyes, and claustrophobia.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Daniel S. Berman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel S. Berman, M.D.</last_name>
    <phone>310 423-4223</phone>
    <email>bermand@cshs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rhona Littman</last_name>
    <phone>310 423-4387</phone>
    <email>littmanr@cshs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Daniel S. Berman, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Daniel S. Berman</investigator_full_name>
    <investigator_title>Principal Investigator/Chief Cardiac Imaging/Nuclear Cardiology</investigator_title>
  </responsible_party>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>MRI</keyword>
  <keyword>Positron Emission Tomography</keyword>
  <keyword>PET</keyword>
  <keyword>PET-MR</keyword>
  <keyword>mMR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT02249520
org study id: 35521
nct id: NCT02249520
lead sponsor: 
has dmc: No
This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens
      Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner
      and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical
      Imaging Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR
      is a FDA-approved standard clinical device (non-experimental) and will be used in accordance
      with clearance and approval from the FDA. The Vida is a state-of-the-art FDA approved scanner
      and will be clinically licensed within a short time.
PET-MR Protocol on the Biograph mMR: This protocol requires the use of a radioisotope. To
      avoid administering radioisotope solely for the purposes of this calibration, we will recruit
      20 patients from the clinical population at the S. Mark Taper Foundation Imaging Center at
      CSMC who are already receiving an isotope dose for their standard-of-care examination and are
      willing to be scanned at the Research Imaging Core on the same day right after their clinical
      exam. Subjects who are having a PET-MR after receiving FDG will have the same body part
      scanned as they did for clinical testing.

      MR-only Protocol on the Biograph mMR:To set up MR-only protocols, we will enroll 20
      volunteers for MR-only on the mMR scanner. This is a standard MR scan with no isotope
      involved. Those volunteers who are participating in the MR-only scan will have major body
      parts and organs scanned as needed for calibration.

      MR imaging on the Siemens Vida 3T scanner: applications training is taking place and we will
      build clinical protocols in the future
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: composite of measures of organ uptake, maximum target-to-background ratio and maximum standard uptake value as standard with FDG PET for maximum image quality for all standard protocols.
time frame: one day
description: The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. Results obtained from these tests will not be analyzed towards the end point of any study and will solely be used to finalize and calibrate the technical performance of the new scanner. All scans will be visually assessed for technique calibration.
arm group label: PET-MR imaging on Biograph mMR scanner
arm group type: Other
description: Research PET-MR imaging on Biograph mMR scanner will be conducted immediately following administration of FDG for clinically approved scan. No additional radioisotope will be administered for the research scan.
arm group label: MR-only imaging on Biograph mMR scanner
arm group type: Other
description: Participants will undergo research MR-only imaging on Biograph mMR scanner.
arm group label: MR imaging on the Siemens Vida 3T MR scanner
arm group type: Other
description: Participants will undergo research MR imaging on the Siemens MR scanner
intervention type: Other
intervention name: PET-MR imaging on Biograph mMR scanner
description: Participants will undergo PET-MR imaging on the Biograph mMR scanner to evaluate the technical aspects of the total acquisition protocol directly post clinical administration of FDG, thus removing the requirement for additional radioisotope.
arm group label: PET-MR imaging on Biograph mMR scanner
other name: Siemens Biograph mMR
other name: molecular imaging
other name: PET-MR
other name: mMR
intervention type: Other
intervention name: MR-only imaging on Biograph mMR scanner
description: Participants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered.
arm group label: MR-only imaging on Biograph mMR scanner
other name: Siemens Biograph mMR
other name: PET-MR
intervention type: Other
intervention name: MR imaging on the Siemens Vida 3T MR scanner
description: Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner
arm group label: MR imaging on the Siemens Vida 3T MR scanner
other name: MRI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel S. Berman, M.D.
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Daniel S. Berman, M.D.
phone: 310 423-4223
email: bermand@cshs.org
last name: Rhona Littman
phone: 310 423-4387
email: littmanr@cshs.org
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Daniel S. Berman
investigator title: Principal Investigator/Chief Cardiac Imaging/Nuclear Cardiology
mesh term: Coronary Artery Disease