<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/NCT03033615</url>
  </required_header>
  <id_info>
    <org_study_id>ALG-002</org_study_id>
    <nct_id>NCT03033615</nct_id>
  </id_info>
  <brief_title>PixelShine vs. Iterative Reconstruction (IR) Processing of CT Images</brief_title>
  <official_title>Prospective Review of CT Imaging Data Comparing Quality of Low-Radiation-Dose Images Post-Processed With Iterative Reconstruction Software vs. Machine Learning (AlgoMedica PixelShine) Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AlgoMedica, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AlgoMedica, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the quality of CT images acquired with very low-dose radiation and&#xD;
      processed with commercially available software vs. PixelShine processed images. It would&#xD;
      potentially allow imaging facilities to acquire CT scans using lower doses of radiation&#xD;
      without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose&#xD;
      radiation has the potential to enhance patient safety and has significant implications in&#xD;
      imaging practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients receiving CT scans as part of their standard treatment will be asked to consent to&#xD;
      an additional 5 minutes of imaging using very low-dose radiation prior to the&#xD;
      conventional-dose CT scan. The prospective review will be performed in two cohorts: Chest CT&#xD;
      scans and abdominal CT scans.&#xD;
&#xD;
      Anonymized images will be processed by conventional CT software and compared to the same&#xD;
      images processed with machine-learning-based PixelShine. A board-certified radiologist will&#xD;
      assess the noise and visual quality of the imaging data.&#xD;
&#xD;
      Study patients will receive approximately 10% more dose than a standard CT scan by&#xD;
      participating in the study. There are no known short-term safety issues associated with this&#xD;
      study. The study-related very low dose radiation is at a level far below that used for&#xD;
      conventional x-ray imaging. The study has been approved by the Radiation Safety Committee as&#xD;
      part of the review process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Image Quality as Assessed by Image Noise Reduction</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
    <description>Comparison of image noise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Image Resolution as Assessed by Size of Detected Lesions</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
    <description>Determine smallest size of detectable objects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cancer, Lung</condition>
  <condition>Cancer Liver</condition>
  <condition>X-rays; Effects</condition>
  <arm_group>
    <arm_group_label>Chest CT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional processing vs. PixelShine processing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abdominal CT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional processing vs. PixelShine processing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PixelShine</intervention_name>
    <description>Machine learning algorithm</description>
    <arm_group_label>Abdominal CT</arm_group_label>
    <arm_group_label>Chest CT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional processing</intervention_name>
    <description>Iterative reconstruction software</description>
    <arm_group_label>Abdominal CT</arm_group_label>
    <arm_group_label>Chest CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be 18 years of age or older&#xD;
&#xD;
          -  Patients must be able and willing to consent to participate in this project&#xD;
&#xD;
          -  Patients will be scheduled for a standard of care CT scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  This study does not investigate either a specific disease or a specific patient&#xD;
             population-it only examines and compares images obtained at low radiation exposure&#xD;
             post-processed with Algomedica's PixelShine software with conventionally processed&#xD;
             images&#xD;
&#xD;
          -  All other patients will be excluded&#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>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 5, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_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/NCT03033615
org study id: ALG-002
nct id: NCT03033615
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will compare the quality of CT images acquired with very low-dose radiation and
      processed with commercially available software vs. PixelShine processed images. It would
      potentially allow imaging facilities to acquire CT scans using lower doses of radiation
      without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose
      radiation has the potential to enhance patient safety and has significant implications in
      imaging practices.
Patients receiving CT scans as part of their standard treatment will be asked to consent to
      an additional 5 minutes of imaging using very low-dose radiation prior to the
      conventional-dose CT scan. The prospective review will be performed in two cohorts: Chest CT
      scans and abdominal CT scans.

      Anonymized images will be processed by conventional CT software and compared to the same
      images processed with machine-learning-based PixelShine. A board-certified radiologist will
      assess the noise and visual quality of the imaging data.

      Study patients will receive approximately 10% more dose than a standard CT scan by
      participating in the study. There are no known short-term safety issues associated with this
      study. The study-related very low dose radiation is at a level far below that used for
      conventional x-ray imaging. The study has been approved by the Radiation Safety Committee as
      part of the review process.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Visual Image Quality as Assessed by Image Noise Reduction
time frame: Through study completion, an average of 1 month
description: Comparison of image noise
measure: Image Resolution as Assessed by Size of Detected Lesions
time frame: Through study completion, an average of 1 month
description: Determine smallest size of detectable objects
arm group label: Chest CT
arm group type: Active Comparator
description: Conventional processing vs. PixelShine processing
arm group label: Abdominal CT
arm group type: Active Comparator
description: Conventional processing vs. PixelShine processing
intervention type: Device
intervention name: PixelShine
description: Machine learning algorithm
arm group label: Abdominal CT
arm group label: Chest CT
intervention type: Device
intervention name: Conventional processing
description: Iterative reconstruction software
arm group label: Abdominal CT
arm group label: Chest CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No