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| Name | Class |
|---|---|
| University of Dundee | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A single measurement of the patient's abdominal depth | Other | A single measurement of the patient's anterior-posterior abdominal depth |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the Computational Model | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Ambulatory outpatients attending Ninewells Hospital's radiology department for an anterior-posterior abdomen x-ray examination
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Vinnicombe, MD | University of Dundee | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Tayside | Dundee | Angus | DD1 9SY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 abdominal depth: A single measurement of the patient's anterior-posterior abdominal depth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 abdominal depth: A single measurement of the patient's anterior-posterior abdominal depth |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of the Computational Model | 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. | Posted | Mean | Standard Deviation | percentage agreement (est/measured) | 2 months |
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1 day
There was no harm possible as a result of this trial. Therefore, all-cause mortality, serious and other [not including serious] adverse events were not monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 abdominal depth: A single measurement of the patient's anterior-posterior abdominal depth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Worrall | NHS Tayside | 01382632177 | markworrall@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2017 | Jun 10, 2019 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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