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OpenTrials
Completed

NCT Number: NCT03935737

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.

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Key information

Conditions

Chest X-ray for Clinical Evaluation

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full Dose Chest X-Ray

Diagnostic Test

Full dose X ray at Day 1

Other names: GM85

Low Dose Chest X-Ray

Diagnostic Test

Low dose X ray within 3 months from full dose

Other names: GM85

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Samsung Electronics

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 2, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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