Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate efficacy and safety of AI-assisted radiotherapy contouring software in CT images for thoracic organs at risk. After screening, qualified participants' thoracic CT images will be anonymized and randomized to two sequences, one with independent investigator contouring of thoracic organs at risk, followed by washout period and software-assisted contouring, and the other in reverse sequence. The washout period lasts for at least 4 weeks. Investigators will not only contour organs at risk in their own center, but also organs in the previous center. The anonymized images will be contoured by independent expert team as the golden standard. The experimental group refers to software-assisted contouring, while the control group refers to independent investigator contouring. Judged by the golden standard, the two groups will be compared to evaluate efficacy and safety of software-assisted contouring of thoracic organs at risk.

Official Title
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Prospective, Multicenter and Controlled Evaluation of Efficacy and Safety of AI-assisted Radiotherapy Contouring Software in CT Images for Thoracic Organs at Risk

Conditions
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Lung Cancer, Breast Cancer, Esophageal Cancer

Intervention / Treatment
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* Device: contouring of thoracic organs at risk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old, no gender limit； patients suffering from breast cancer or lung cancer or esophageal cancer, undergoing thoracic CT scan, ready for radiotherapy； CT slice thickness ≤5mm； patients understand the goal of the trial, are willing to attend the trial and sign the informed consent. Exclusion Criteria: congenital malformation or anatomical anomaly in scanned sites; artifact, prosthesis or implantation causing images undistinguishable; CT images not conforming to DICOM standards； investigators consider not suitable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>independent investigator contouring of thoracic organs at risk | Device: contouring of thoracic organs at risk<br>* The thoracic organs at risk will be contoured by investigators independently, and by investigators assisted with software, at different time points. Judged by the golden standards established by the expert team, the contours will be evaluated. But the contoured organs in any group will not be applied in radiotherapy.<br>|
| experimental group<br>software-assisted contouring of thoracic organs at risk | Device: contouring of thoracic organs at risk<br>* The thoracic organs at risk will be contoured by investigators independently, and by investigators assisted with software, at different time points. Judged by the golden standards established by the expert team, the contours will be evaluated. But the contoured organs in any group will not be applied in radiotherapy.<br>|
| golden standard group<br>contouring of thoracic organs at risk by a team of experts, in which contours by two experts separately will be arbitrated by the third expert as the golden standard | Device: contouring of thoracic organs at risk<br>* The thoracic organs at risk will be contoured by investigators independently, and by investigators assisted with software, at different time points. Judged by the golden standards established by the expert team, the contours will be evaluated. But the contoured organs in any group will not be applied in radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DICE | DICE= 2×（A∩B）/(A+B), A refers to golden standard, B refers to control or experimental group | through study completion, an average of 6 months | 
| contouring time | from time of CT loaded to end of contouring | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of volume， DV | DV = (A-B) /B× 100%, A refers to golden standard, B refers to control or experimental group | through study completion, an average of 6 months | 
| recall, Rec | Rec = | A∩B| / A, A refers to golden standard, B refers to control or experimental group | through study completion, an average of 6 months | 
| precision， Pre | Pre= |A∩B| / B, A refers to golden standard, B refers to control or experimental group | through study completion, an average of 6 months | 
| rate of efficiency improvement | rate of efficiency improvement= (duration of independent investigator contouring-duration of software-assisted contouring)/ duration of independent investigator contouring*100% | through study completion, an average of 6 months | 
| satisfaction for AI contouring | satisfaction assessment utilizing Likert scale: 1, very unsatisfied; 2, somewhat unsatisfied; 3, modest; 4, somewhat satisfied; 5, very satisfied. | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence, Radiotherapy, contouring, thoracic organs at risk