Chest X-ray for Clinical EvaluationNCT03935737
Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients
An observational study of Chest X-ray for Clinical Evaluation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Chest X-ray for Clinical Evaluation
- What is being tested?
- Full Dose Chest X-Ray and Low Dose Chest X-Ray
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2018to 22 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients seen in clinic.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
- Being tested
- Full Dose Chest X-Ray, Low Dose Chest X-Ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Dose Chest X-RayDiagnostic test
Also called GM85
Full dose X ray at Day 1
Low Dose Chest X-RayDiagnostic test
Also called GM85
Low dose X ray within 3 months from full dose
| Study group | Role | What they receive |
|---|---|---|
| Full dose Chest X-Ray | Subjects will receive a full (standard) dose chest X-ray at Day 1. Receives: 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. Receives: Diagnostic Test: Low Dose Chest X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start26 Oct 2018
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest X-ray for Clinical EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Susan D John, The University of Texas Health Science Center, Houston
- Investigators
- Susan D John, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935737
- Sponsor's protocol ID
- HSC-MS-18-0348
- Status last verified
- Mar 2020
- First submitted
- 25 Apr 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03935737
- Acronym / sponsor ID
- HSC-MS-18-0348
- Conditions
- Chest X-ray for Clinical Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full dose Chest X-Ray | – | Diagnostic Test: Full Dose Chest X-RaySubjects will receive a full (standard) dose chest X-ray at Day 1. |
| Low dose Chest X-Ray | – | Diagnostic Test: Low Dose Chest X-RaySubjects will receive a follow up X-ray at at a lower dose within 3 months after the first dose. |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients seen in clinic.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Dose Chest X-RayAlso: GM85Full dose X ray at Day 1 | Diagnostic test | Full dose Chest X-Ray |
| Low Dose Chest X-RayAlso: GM85Low dose X ray within 3 months from full dose | Diagnostic test | Low dose Chest X-Ray |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan D John, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest X-ray for Clinical Evaluation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmark (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.