AI-Based Analysis of Port Catheter Tip Position
ConditionVascular Access Devices
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBagcilar Training and Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Planned placement of a totally implantable venous access port through the right internal jugular vein as part of routine clinical care.
Availability of a suitable pre-implantation chest radiograph obtained as part of routine clinical care.
Availability of a clinically indicated post-implantation noncontrast chest computed tomography examination.
Disqualifiers
Age younger than 18 years.
Cancellation of the routine clinical port implantation plan.
Planned or performed port placement through a venous access route other than the right internal jugular vein.
No suitable pre-implantation chest radiograph available for study assessment.
Trial population
Adults aged 18 years or older scheduled for right internal jugular vein placement of a totally implantable venous access port at Bagcilar Training and Research Hospital will be screened consecutively for this single-center prospective observational study. Enrollment will require written informed consent and confirmation of all eligibility criteria, including availability of a clinically indicated post-implantation noncontrast chest computed tomography (CT) examination and absence of documented catheter manipulation or revision before the selected CT. CT reference evaluability and generation of a valid automated output will determine the relevant analysis populations and will not be prerequisites for enrollment. No additional imaging will be performed for research purposes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AI-Based Automated Image Analysis
Diagnostic testThe 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
Diagnostic testThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Prospective Port Catheter Cohort2 interventions
Trial outcomes
Primary outcomes
1
Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
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.
Time frame
At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revisionSecondary outcomes
1
Median Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Median absolute error (MedAE), in millimeters, will be calculated as the median 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 participant-level bootstrap resampling.
Time frame
At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision2
Root Mean Squared Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Root mean squared error (RMSE), in millimeters, will be calculated as the square root of the arithmetic mean of the squared 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 overall estimation error, and larger individual errors have greater influence because differences are squared before averaging. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Time frame
At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision3
Mean Signed Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Mean signed error, in millimeters, will be calculated as the arithmetic mean of the catheter advancement length estimated by the locked AI-based automated A+B+Delta method minus 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. Positive values indicate that the automated method estimates a longer advancement length than the reference, negative values indicate a shorter estimate, and zero indicates no average directional error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Time frame
At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision4
Mean Paired Difference in Absolute Error Between the AI-Based Automated A+B+Delta and Manual A+B Methods
For each participant, absolute error will be calculated for both the locked AI-based automated A+B+Delta method and the manual A+B method relative to the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The paired difference, in millimeters, will be calculated as automated absolute error minus manual absolute error, and its arithmetic mean will be reported. The analysis population will include participants with an evaluable reference measurement and valid estimates from both methods. Negative values indicate a smaller absolute error for the automated method, positive values indicate a smaller absolute error for the manual method, and zero indicates no average paired difference. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Time frame
At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revisionOther outcomes
1
Huber Regression Slope for the Association Between the Port Implantation-to-CT Interval and Signed Error
In this prespecified exploratory analysis, the association between the interval from port implantation to the first eligible post-implantation noncontrast chest computed tomography examination and the signed error of the locked AI-based automated A+B+Delta method will be assessed among participants with a valid automated output and an evaluable CT-derived reference measurement. Signed error, in millimeters, will be defined as the automated catheter advancement length estimate minus the CT-derived reference length. The interval, recorded in hours, will be transformed as log2(1 + hours). A robust Huber regression slope with a two-sided 95% confidence interval will be reported; Spearman's rank correlation coefficient with a two-sided 95% confidence interval will be an auxiliary analysis. Raw and Holm-adjusted Spearman p-values will be reported. The slope is expressed in millimeters per log2(1 + hours); positive values indicate increasingly positive signed error with longer intervals.
Time frame
At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision2
Huber Regression Slope for the Association Between the Port Implantation-to-CT Interval and Absolute Error
In this prespecified exploratory analysis, the association between the interval from port implantation to the first eligible post-implantation noncontrast chest computed tomography examination and the absolute error of the locked AI-based automated A+B+Delta method will be assessed among participants with a valid automated output and an evaluable CT-derived reference measurement. Absolute error, in millimeters, will be defined as the absolute difference between the automated catheter advancement length estimate and the CT-derived reference length. The interval, recorded in hours, will be transformed as log2(1 + hours). A robust Huber regression slope with a two-sided 95% confidence interval will be reported; Spearman's rank correlation coefficient with a two-sided 95% confidence interval will be an auxiliary analysis. Raw and Holm-adjusted p-values will be reported for the Spearman test. Slope is in millimeters per log2(1 + hours); positive values indicate increasing absolute error.
Time frame
At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revisionSponsors and contacts
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Source ClinicalTrials.gov
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