AI-Based Analysis of Port Catheter Tip Position

Condition(s) studied

Investigational drug(s) / intervention(s)

AI-Based Automated Image Analysis: The locked automated method will use chest radiographic image analysis and a patient-specific Delta adjustment to estimate port catheter tip position. The method will be evaluated offline using reference measurements derived from clinically indicated post-implantation noncontrast chest computed tomography. Its output will not be provided to the clinical team and will not guide port implantation or alter clinical decisions.

Manual A+B Measurement Method: The prespecified manual A+B method will estimate port catheter tip position using manual measurements on the pre-implantation chest radiograph. It will be applied as a comparator in the same participants. The manual research measurement will not guide port implantation or alter clinical care.

Study summary

This prospective, single-center observational study will evaluate the performance of an artificial intelligence (AI)-based automated image-analysis method that will be developed, internally tested, and locked before prospective enrollment. The method will estimate the position of totally implantable venous access port catheter tips in adults undergoing right internal jugular vein port implantation as part of routine care. The automated estimate will be compared with a prespecified manual measurement method. Reference measurements of the catheter tip and the cavoatrial junction will be obtained from clinically indicated chest computed tomography images when both structures are visible. No additional chest radiography or computed tomography will be performed for research purposes, and the automated output will not guide catheter placement or alter clinical decisions. The primary performance measure will be the mean absolute error of the automated estimate in the prospective cohort.

Eligibility

Primary outcome measure(s)

• Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method — At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
  Mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using 10,000 participant-level bias-corrected and accelerated bootstrap resamples.

Trial sites (1)

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