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

Chest X-ray for Clinical Evaluation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935737
• Other study ID #: HSC-MS-18-0348
• Status: Completed
• Start date: October 26, 2018
• Est. completion date: March 22, 2019

Study information

• Verified date: March 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest X-ray for Clinical Evaluation

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Samsung Electronics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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