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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Esophageal Cancer; Lung Cancer
• Intervention / Treatment: Device: contouring of thoracic organs at risk

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Yong Guan, MD; Phone Number: 5506 +862223340123; Email: alan099015@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
      • Contact: Zhao Yan; Phone Number: 5509 +86-22-23340123; Email: yanzhaotj@126.com
      • Principal Investigator: Xishan Hao, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients, male or female, with breast cancer, lung cancer or esophageal cancer, with age ≥18 years old, can be enrolled into this study.

Description

Inclusion Criteria:

1. ≥18 years old, no gender limit；
2. patients suffering from breast cancer or lung cancer or esophageal cancer, undergoing thoracic CT scan, ready for radiotherapy；
3. CT slice thickness ≤5mm；
4. patients understand the goal of the trial, are willing to attend the trial and sign the informed consent.

Exclusion Criteria:

1. congenital malformation or anatomical anomaly in scanned sites;
2. artifact, prosthesis or implantation causing images undistinguishable;
3. CT images not conforming to DICOM standards；
4. investigators consider not suitable.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; independent investigator contouring of thoracic organs at risk	Device: contouring of thoracic organs at risk; 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.
experimental group; software-assisted contouring of thoracic organs at risk	Device: contouring of thoracic organs at risk; 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.
golden standard group; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	adverse events during CT scanning	during CT 1 day scanning
device defect	software malfunction	1 day (during the process of contouring)

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Shanxi Province Cancer Hospital; Fifth Affiliated Hospital, Sun Yat-Sen University; Wuhan Union Hospital, China; Nanxishan Hospital of Guangxi Zhuang Autonomous Region; Guangzhou Perception Vision Medical Technology Co. Ltd
• Investigators: Principal Investigator: Zhiyong Yuan, Ph.D., Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy; Artificial Intelligence; contouring; thoracic organs at risk
• Other Study ID Numbers: PVMEDCT202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No