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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03341546
Other study ID # 2017RA01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2018
Est. completion date August 24, 2018

Study information

Verified date June 2019
Source NHS Tayside
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 24, 2018
Est. primary completion date May 7, 2018
Accepts healthy volunteers No
Gender All
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Testing a Computational Model to Estimate Patient Size

Intervention

Other:
A single measurement of the patient's abdominal depth
A single measurement of the patient's anterior-posterior abdominal depth

Locations

Country Name City State
United Kingdom NHS Tayside Dundee Angus

Sponsors (2)

Lead Sponsor Collaborator
NHS Tayside University of Dundee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
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.
2 months