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NOT YET RECRUITING
NCT07791875

AI-Based Analysis of Port Catheter Tip Position

Sponsor: Bagcilar Training and Research Hospital

View on ClinicalTrials.gov

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.

Official title: Determination of Port Catheter Tip Position Using Artificial Intelligence-Based Automated Image Analysis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-10-05

Completion Date

2026-11

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Locations (1)

Bagcilar Training and Research Hospital

Bağcılar, Istanbul, Turkey (Türkiye)