Determination of Port Catheter Tip Position Using Artificial Intelligence-Based Automated Image Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
研究概览
简要总结
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.
详细描述
Before prospective enrollment, a two-dimensional nnU-Net-based multitask model will be developed and internally tested using retrospective chest radiographs from the same center. The model parameters, ensemble, preprocessing steps, and technical output rules will be locked before prospective enrollment. The retrospective development and internal test datasets are not part of the enrollment reported for this record.
The prospective component will include one observational cohort of adults aged 18 years or older undergoing right internal jugular vein port implantation during routine clinical care. Implantation, chest radiography, computed tomography, and all clinical management decisions will remain under the responsibility of the treating clinical team and will not be assigned by the research protocol. The automated output will not be made available for procedural guidance or patient management.
For each evaluable participant, the locked automated method will generate an estimate based on chest radiographic image analysis and a patient-specific Delta adjustment. A prespecified manual A+B measurement method will be applied as a comparator in the same participants. Reference measurements will be derived from the first suitable post-implantation noncontrast chest computed tomography examination obtained for a routine clinical indication, provided that both the catheter tip and the cavoatrial junction are visible and no catheter manipulation occurred beforehand. No additional radiographic or computed tomography examination will be requested for the study.
The primary objective is to quantify the error of the automated estimate using mean absolute error in the prospective cohort. Prespecified secondary analyses will evaluate additional error, agreement, pragmatic accuracy, technical assessability, and repeatability measures. The ±10 mm criterion will be treated as a pragmatic accuracy threshold rather than a clinical safety boundary. The study is a same-center prospective performance evaluation; it is not an external validation and is not designed to assess clinical benefit or to establish that the system is ready for clinical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Absence of documented catheter manipulation or revision before the selected post-implantation computed tomography examination.
- •Provision of written informed consent.
排除标准
- •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.
- •Advanced thoracic deformity or mediastinal distortion precluding the required study measurements.
- •Inability or unwillingness to provide written informed consent.
研究组 & 干预措施
Prospective Port Catheter Cohort
Adults aged 18 years or older undergoing totally implantable venous access port implantation through the right internal jugular vein as part of routine clinical care will be enrolled in a single prospective observational cohort. In each evaluable participant, the locked AI-based automated A+B+Delta method and the prespecified manual A+B measurement method will be assessed using reference measurements from clinically indicated post-implantation noncontrast chest computed tomography. No research-specific imaging will be performed, and the automated output will not guide port implantation or alter clinical decisions.
干预措施: AI-Based Automated Image Analysis (Diagnostic Test)
Prospective Port Catheter Cohort
Adults aged 18 years or older undergoing totally implantable venous access port implantation through the right internal jugular vein as part of routine clinical care will be enrolled in a single prospective observational cohort. In each evaluable participant, the locked AI-based automated A+B+Delta method and the prespecified manual A+B measurement method will be assessed using reference measurements from clinically indicated post-implantation noncontrast chest computed tomography. No research-specific imaging will be performed, and the automated output will not guide port implantation or alter clinical decisions.
干预措施: Manual A+B Measurement Method (Diagnostic Test)
结局指标
主要结局
Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
时间窗: 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.
次要结局
- Median 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)
- Root Mean Squared 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 Signed 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 Paired Difference in Absolute Error Between the AI-Based Automated A+B+Delta and Manual A+B Methods(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)
- Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)
- Paired Difference in Proportions of Estimates With Absolute Error Within 10 mm Between the AI-Based Automated A+B+Delta and Manual A+B Methods(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)
- Technical Success Rate of the AI-Based Automated A+B+Delta Method(At baseline, during offline analysis of the pre-implantation chest radiograph obtained before port implantation)
- Intraobserver Agreement of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance Assessed by ICC(A,1)(At repeat assessment of the CT-derived reference measurement after a 4-week washout period)
- Mean Intraobserver Difference in the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance(At repeat assessment of the CT-derived reference measurement after a 4-week washout period)
- Within-Subject Standard Deviation of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance(At repeat assessment of the CT-derived reference measurement after a 4-week washout period)
- Repeatability Coefficient of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance(At repeat assessment of the CT-derived reference measurement after a 4-week washout period)
- Mean Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)
- Median Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)
- Root Mean Squared Error of Catheter Advancement Length Estimated by the Manual A+B Method(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)
- Mean Signed Error of Catheter Advancement Length Estimated by the Manual A+B 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 of the AI-Based Automated A+B+Delta Method Within 24 Hours After Port Implantation and Before Catheter Manipulation(Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care)
- Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm Within 24 Hours After Port Implantation and Before Catheter Manipulation(Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care)
- Bland-Altman Limits of Agreement for the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance(At repeat assessment of the CT-derived reference measurement after a 4-week washout period)
- Bland-Altman Limits of Agreement Between the AI-Based Automated A+B+Delta Estimate and the CT-Derived Reference(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)
- Bland-Altman Limits of Agreement Between the Manual A+B Estimate and the CT-Derived Reference(At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision)