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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chest X-ray for Clinical Evaluation

Intervention / Treatment
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* Diagnostic Test: Full Dose Chest X-Ray
* Diagnostic Test: Low Dose Chest X-Ray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full dose Chest X-Ray<br>Subjects will receive a full (standard) dose chest X-ray at Day 1. | Diagnostic Test: Full Dose Chest X-Ray<br>* Full dose X ray at Day 1<br>* Other names: GM85;|
| Low dose Chest X-Ray<br>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<br>* Low dose X ray within 3 months from full dose<br>* Other names: GM85;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |