Clinical Validation of AI-Assisted Radiotherapy Contouring Software for Thoracic Organs At Risk

NCT ID: NCT05787522

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-03-06

Brief Summary

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The goal of this clinical trial is to evaluate performance and clinical applicability of AI-assisted radiotherapy contouring software for thoracic organs at risk. The main question it aims to answer is:

• Does AI-assisted contouring (AI contouring with manual modification) offer greater accuracy and time efficiency compared to manual contouring? After screening, the qualified participants' thoracic CT images will be anonymized and segmented using three methods: manual, AI (AI-only), and AI-assisted contouring. The researchers will compare the results generated by the three different contouring methods with the ground truth established by expert consensus, in order to evaluate both accuracy and time-related parameters

Detailed Description

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Conditions

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Lung Cancer Breast Cancer Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Independent manual contouring

Manual contouring refers to physicians using the brush tool on the contouring platform to segment thoracic organs at risk manually, without the use of auto-segmentation tools.

No interventions assigned to this group

AI contouring

AI contouring refers to the auto-segmentation results generated by the Res-SE Net model, with the model integrated into the auto-segmentation software.

No interventions assigned to this group

AI-assisted contouring

After generating the AI contouring results, investigators will import them into the contouring platform and perform manual modifications, producing the AI-assisted contouring.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. ≥18 years old, no gender limit.
2. Patients diagnosed with breast cancer, lung cancer, or esophageal cancer, who are scheduled for chest CT scanning followed by thoracic 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 malformations or abnormal anatomical structures resulting from non-tumor factors in the scan area.
2. Artifact, prosthesis or implantation causing images undistinguishable.
3. CT images not conforming to DICOM standards.
4. Investigators consider not suitable.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Perception Vision Medical Technology Co. Ltd

UNKNOWN

Sponsor Role collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhiyong Yuan

Head of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiyong Yuan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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PVMEDCT202201

Identifier Type: -

Identifier Source: org_study_id

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