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 University of Texas System (UT)

Status: Completed

Conditions: Chest X-ray for Clinical Evaluation

Treatments: Diagnostic Test: Full Dose Chest X-Ray; Diagnostic Test: Low Dose Chest X-Ray

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03935737

HSC-MS-18-0348

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 1 month to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Full dose Chest X-Ray

Description:

Subjects will receive a full (standard) dose chest X-ray at Day 1.

Treatment:

Diagnostic Test: Full Dose Chest X-Ray

Low dose Chest X-Ray

Description:

Subjects will receive a follow up X-ray at at a lower dose within 3 months after the first dose.

Treatment:

Diagnostic Test: Low Dose Chest X-Ray