<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/NCT04417998</url>
  </required_header>
  <id_info>
    <org_study_id>19-010591</org_study_id>
    <nct_id>NCT04417998</nct_id>
  </id_info>
  <brief_title>Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction</brief_title>
  <official_title>Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of new software available on a new&#xD;
      PET/CT scanner in the Molecular Imaging Research PET/CT Facility. Further, the study aims to&#xD;
      evaluate the data acquisition and image processing workflow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be separated into three cohorts: Motion Correction, Parametric Imaging, and&#xD;
      MAP Reconstruction. The motion correction (Aim 1) cohort will involve a group of 30 subjects&#xD;
      who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe)&#xD;
      and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system in the&#xD;
      PET/CT Molecular Imaging Research Center in Charlton 6 of Mayo Clinic Rochester. The data&#xD;
      gathered from this cohort will assess the effectiveness of motion correction software for&#xD;
      patients undergoing PET brain scans. The parametric imaging (Aim 2) cohort will include 30&#xD;
      subjects that have recently undergone a brain or whole body oncologic PET/CT scans on the&#xD;
      V600-R1. The purpose of this cohort is to assess the data acquisition and image processing&#xD;
      workflow for parametric analysis of brain and whole body scans. The MAP Reconstruction Cohort&#xD;
      (Aim 3) is a retrospective study to assess the quality of PET images reconstructed with&#xD;
      maximum a posteriori (MAP) reconstruction algorithm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to two groups in parallel for the duration of the study. Aim 1 involves the prospective data collection of subjects who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. Aim 2 involves the prospective data collection of subjects undergoing brain or whole body oncologic PET/CT scans on the V600-R1.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motion Correction</measure>
    <time_frame>2 years</time_frame>
    <description>Confirm that motion-corrected reconstructed images acquired when the subject was moving provides similar image quality to the baseline reference reconstructed images acquired when the subject was instructed to remain still.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parametric Imaging</measure>
    <time_frame>2 years</time_frame>
    <description>Metabolic rate of 18F-FDG measured from dynamic PET images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Map Reconstruction</measure>
    <time_frame>2 years</time_frame>
    <description>Confirm that maximum a posteriori reconstructed PET images are diagnostically acceptable</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Brain Imaging</condition>
  <condition>Whole Body Imaging</condition>
  <arm_group>
    <arm_group_label>Motion Correction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aim 1 involves the prospective data collection of subjects who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. The purpose of this arm is to evaluate the effectiveness of motion correction software.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parametric Imaging</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aim 2 involves the prospective data collection of subjects undergoing brain or whole body oncologic PET/CT scans on the V600-R1. The purpose of this arm is to evaluate the data acquisition and image processing workflow.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-FDG</intervention_name>
    <description>A cohort of participants in Aim 2 will undergo a 18F-FDG PET/CT scan. This scan is done with a radiotracer called 18F-fluorodeoxyglucose (FDG). FDG looks at cellular activity.</description>
    <arm_group_label>Parametric Imaging</arm_group_label>
    <other_name>FDG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-AV1451</intervention_name>
    <description>A cohort of participants in Aim 2 will undergo a 18F-AV1451 PET/CT scan. This scan is done with a radiotracer called 18F-AV1451 (TAU) that will find small areas of tau (abnormal protein) in the brain.</description>
    <arm_group_label>Parametric Imaging</arm_group_label>
    <other_name>TAU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Siemens E7 Reconstruction Tool</intervention_name>
    <description>Software to correct for motion</description>
    <arm_group_label>Motion Correction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Subjects who are able and willing to sign the informed consent&#xD;
&#xD;
          -  Subjects who are able to follow verbal commands&#xD;
&#xD;
          -  A negative urine pregnancy test within 48 hours prior to PET imaging procedures in&#xD;
             females of childbearing potential&#xD;
&#xD;
          -  Subjects who are scheduled for a PET/CT study under Mayo Clinic Rochester IRB research&#xD;
             protocol 08-005553 (Aim 1 cohort only)&#xD;
&#xD;
          -  A positive 18F-FDG oncology PET/CT exam in the last six months (Aim 2 cohort only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unable to lay still for an additional 15 minutes (for Aim 1 cohort)&#xD;
&#xD;
          -  Patients who are unable to lay still for 90 min for 18F-FDG scans or 100 min for&#xD;
             18F-AV1451 scans (for Aim 2 cohort)&#xD;
&#xD;
          -  Patients who cannot follow the prep instructions&#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>Bradley Kemp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</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>April 2023</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Bradley Kemp</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Brain Imaging</keyword>
  <keyword>Whole Body Imaging</keyword>
  <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/NCT04417998
org study id: 19-010591
nct id: NCT04417998
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
The purpose of this study is to assess the effectiveness of new software available on a new
      PET/CT scanner in the Molecular Imaging Research PET/CT Facility. Further, the study aims to
      evaluate the data acquisition and image processing workflow.
The study will be separated into three cohorts: Motion Correction, Parametric Imaging, and
      MAP Reconstruction. The motion correction (Aim 1) cohort will involve a group of 30 subjects
      who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe)
      and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system in the
      PET/CT Molecular Imaging Research Center in Charlton 6 of Mayo Clinic Rochester. The data
      gathered from this cohort will assess the effectiveness of motion correction software for
      patients undergoing PET brain scans. The parametric imaging (Aim 2) cohort will include 30
      subjects that have recently undergone a brain or whole body oncologic PET/CT scans on the
      V600-R1. The purpose of this cohort is to assess the data acquisition and image processing
      workflow for parametric analysis of brain and whole body scans. The MAP Reconstruction Cohort
      (Aim 3) is a retrospective study to assess the quality of PET images reconstructed with
      maximum a posteriori (MAP) reconstruction algorithm.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to two groups in parallel for the duration of the study. Aim 1 involves the prospective data collection of subjects who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. Aim 2 involves the prospective data collection of subjects undergoing brain or whole body oncologic PET/CT scans on the V600-R1.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Motion Correction
time frame: 2 years
description: Confirm that motion-corrected reconstructed images acquired when the subject was moving provides similar image quality to the baseline reference reconstructed images acquired when the subject was instructed to remain still.
measure: Parametric Imaging
time frame: 2 years
description: Metabolic rate of 18F-FDG measured from dynamic PET images
measure: Map Reconstruction
time frame: 2 years
description: Confirm that maximum a posteriori reconstructed PET images are diagnostically acceptable
arm group label: Motion Correction
arm group type: Active Comparator
description: Aim 1 involves the prospective data collection of subjects who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. The purpose of this arm is to evaluate the effectiveness of motion correction software.
arm group label: Parametric Imaging
arm group type: Active Comparator
description: Aim 2 involves the prospective data collection of subjects undergoing brain or whole body oncologic PET/CT scans on the V600-R1. The purpose of this arm is to evaluate the data acquisition and image processing workflow.
intervention type: Drug
intervention name: 18F-FDG
description: A cohort of participants in Aim 2 will undergo a 18F-FDG PET/CT scan. This scan is done with a radiotracer called 18F-fluorodeoxyglucose (FDG). FDG looks at cellular activity.
arm group label: Parametric Imaging
other name: FDG
intervention type: Drug
intervention name: 18F-AV1451
description: A cohort of participants in Aim 2 will undergo a 18F-AV1451 PET/CT scan. This scan is done with a radiotracer called 18F-AV1451 (TAU) that will find small areas of tau (abnormal protein) in the brain.
arm group label: Parametric Imaging
other name: TAU
intervention type: Device
intervention name: Siemens E7 Reconstruction Tool
description: Software to correct for motion
arm group label: Motion Correction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bradley Kemp, PhD
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: Bradley Kemp
investigator title: Principal Investigator
mesh term: Fluorodeoxyglucose F18
sharing ipd: No