Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients

Overview

The purpose of this study is to compare X-ray images obtained using the GM85 digital radiography machine at the standard full dose to X-ray images obtained using the GM85 digital radiography machine along with the Samsung S-Vue system, which is a image post-processing engine that allows images to be obtained using a lower dose. The study also aims to determine the lowest dose of radiation that can be used to get a good, readable x-ray of the chest in pediatric patients using Samsung S-Vue system.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 22, 2019

Interventions

  • Diagnostic Test: Full Dose Chest X-Ray
    • Full dose X ray at Day 1
  • Diagnostic Test: Low Dose Chest X-Ray
    • Low dose X ray within 3 months from full dose

Arms, Groups and Cohorts

  • Full dose Chest X-Ray
    • Subjects will receive a full (standard) dose chest X-ray at Day 1.
  • Low dose Chest X-Ray
    • Subjects will receive a follow up X-ray at at a lower dose within 3 months after the first dose.

Clinical Trial Outcome Measures

Primary Measures

  • Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmark
    • Time Frame: baseline
    • The BRH anatomic landmark score ranges from 0 to 100 with higher scores indicating better quality.
  • Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmark
    • Time Frame: within 3 months
    • The BRH anatomic landmark score ranges from 0 to 100 with higher scores indicating better quality.
  • Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Physical parameters
    • Time Frame: baseline
    • The BRH physical parameters score ranges from 0 to 100 with higher scores indicating better quality.
  • Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Physical parameters
    • Time Frame: within 3 months
    • The BRH physical parameters score ranges from 0 to 100 with higher scores indicating better quality.

Participating in This Clinical Trial

Inclusion Criteria

  • Standard weight/height outpatients who require two X-ray exams within 3 months in the US
  • BMI is >5% and < 85% for participants over the age of 2;for participants less than 2 weight for length will be measured

Exclusion Criteria

  • Obese and underweight children as defined as BMI ,<5% or >85% according the World Health Organization growth chart for participants over 2 years of age; and for participants less than 2 years of age,weight for length will be measured

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Collaborator
    • Samsung Electronics
  • Provider of Information About this Clinical Study
    • Principal Investigator: Susan D John, Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Susan D John, MD, Principal Investigator, The University of Texas Health Science Center, Houston

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