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

NCT03935737 | Completed FDA Device

• 1 other identifier: HSC-MS-18-0348
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest X-ray for Clinical Evaluation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

Full Dose Chest X-Ray DIAGNOSTIC_TEST

Full dose X ray at Day 1

Also known as: GM85

Full dose Chest X-Ray

Low Dose Chest X-Ray DIAGNOSTIC_TEST

Low dose X ray within 3 months from full dose

Also known as: GM85

Low dose Chest X-Ray

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Samsung Electronics: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Susan D John, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 2, 2019
• Study Start: October 26, 2018
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)