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

Completed

• Conditions: Chest X-ray for Clinical Evaluation
• Interventions: Diagnostic Test: Low Dose Chest X-Ray; Diagnostic Test: Full Dose Chest X-Ray

• Registration Number: NCT03935737
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-26
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low dose Chest X-Ray	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.
Full dose Chest X-Ray	Full Dose Chest X-Ray	Subjects will receive a full (standard) dose chest X-ray at Day 1.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States