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

Tianjin Medical University

Status: Completed

Conditions: Breast Cancer; Esophageal Cancer; Lung Cancer

Treatments: Device: contouring of thoracic organs at risk

Study type: Observational

Funder types: Other

Identifiers

NCT05787522

PVMEDCT202201

Details and patient eligibility

About

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

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 3 patient groups

Independent manual contouring

Description:

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.

AI contouring

Description:

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

AI-assisted contouring

Description:

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