- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341546
Estimating Patient Size From a Single Radiograph (VocMepAdar)
Validation of a Computational Model to Estimate Patient Anterior-posterior Dimension From an Abdominal Radiograph
A computational model has been created to estimate the abdominal depth of a patient from a single x-ray image. The model has been tested using phantoms and found to be accurate; this study aims to test the accuracy of the model with patients and in a clinical setting.
This will be achieved by enrolling patient's who have already been referred for an anterior-posterior abdomen x-ray examination to the trial, taking a physical measurement of their anterior-posterior abdominal depth and then comparing this measured value with a value as estimated using the computational model based on the patient's x-ray image.
Study Overview
Status
Intervention / Treatment
Detailed Description
A non-commercial computational model has been developed in-house to estimate the patient's anterior-posterior or lateral depth using the radiographic image and the known exposure factors with which it was undertaken. This model has been tested using single composition phantoms and found to be accurate. If it was found to be accurate for real clinical examinations, this would automate the measurement of patient size and give institutions the estimate of patient size required for local paediatric patient dose audit. In turn, this would provide the national data required to propose national reference values for paediatric x-ray examinations, which would give all institutions an important comparator for their performance. This would lead to optimisation in those sites most requiring it; nationally, paediatric x-ray imaging would improve in time.
This pilot study is necessary to determine if the computational model is accurate enough to be relied upon. Accuracy will be determined by comparing the estimate made by the computational model for each patient with an actual measurement of the patient's anterior-posterior abdomen depth made at the time of the examination.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Angus
-
Dundee, Angus, United Kingdom, DD1 9SY
- NHS Tayside
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult
- Referred to Ninewells Hospital for an anterior-posterior abdomen x-ray examination
Exclusion Criteria:
- Patients unable to give consent
- Patients who have had a contrast injection in the previous 24 hours
- Patients suffering abdominal pain at the time of the examination
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient cohort
20 patients referred to Ninewells Hospital radiology department for an anterior-posterior abdomen x-ray examination.
All of these patients will have a measurement of their anterior-posterior depth before undergoing their x-ray examination.
An estimate of their anterior-posterior depth will then be made from their x-ray image using the computational model.
|
A single measurement of the patient's anterior-posterior abdominal depth
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of the Computational Model
Time Frame: 2 months
|
The computational model was used to estimate the patient's anterior-posterior abdominal depth using the digital radiographic image, the exposure factors with which it was acquired and a priori knowledge relating to the x-ray unit and digital detector. The outcome measure was the accuracy with which the computational model estimates the patient's anterior-posterior abdominal depth. It was determined by comparing the estimate to measured anterior-posterior abdominal depth (measured at the time of the x-ray examination). Results are expressed as a percentage deviation; a low % deviation is more accurate, a high % deviation less accurate. |
2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Sarah Vinnicombe, MD, University of Dundee
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017RA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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