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

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 Overview

• Status: Completed
• Conditions: Chest X-ray for Clinical Evaluation
• Intervention / Treatment: Diagnostic test: Full Dose Chest X-Ray; Diagnostic test: Low Dose Chest X-Ray

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients seen in clinic.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Full dose Chest X-Ray; Subjects will receive a full (standard) dose chest X-ray at Day 1.	Diagnostic test: Full Dose Chest X-Ray; Full dose X ray at Day 1; Other Names: GM85
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.	Diagnostic test: Low Dose Chest X-Ray; Low dose X ray within 3 months from full dose; Other Names: GM85

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Samsung Electronics
• Investigators: Principal Investigator: Susan D John, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2018
• Primary Completion (Actual): March 22, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-18-0348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No