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

Prospective, Multicenter, Randomized Evaluation of the Performance and Clinical Applicability of AI-Assisted Radiotherapy Contouring Software for Thoracic Organs at Risk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05787522
Enrollment
500
Registered
2023-03-28
Start date
2022-09-30
Completion date
2024-03-06
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Esophageal Cancer, Lung Cancer

Keywords

Artificial Intelligence, Radiotherapy, contouring, thoracic organs at risk

Brief summary

The goal of this clinical trial is to evaluate performance and clinical applicability of AI-assisted radiotherapy contouring software (iCurveE) 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

Interventions

None listed

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER
Guangzhou Perception Vision Medical Technology Co. Ltd
CollaboratorUNKNOWN
People's Hospital of Guangxi Zhuang Autonomous Region
CollaboratorOTHER
Shanxi Province Cancer Hospital
CollaboratorOTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
volumetric DICE similarity coefficient, vDSCWithin 6 months after enrollmentvDSC= 2×(A∩B)/(A+B), where A refers to the volume of the ground truth, and B refers to the volume of the manual, AI, or AI-assisted contour.
Contouring time (min)Within 6 months after enrollmentManual contouring time is recorded from the time the CT is loaded on the contouring platform to the completion of contouring. AI-assisted contouring time is defined as the sum of the auto-segmentation model runtime, the transfer to the contouring platform, and the subsequent manual modification.

Secondary

MeasureTime frameDescription
95th percentile Hausdorff Distance, HD95Within 6 months after enrollmentHD95(A, B) = max (h95(A, B), h95(B, A)), where h95(A, B) is the 95th percentile of the shortest distances from all points on surface A to surface B, and vice-versa for h95(B, A). A represents the ground truth and B represents the manual, AI or AI-assisted delineation
Surface DICE similarity coefficient, sDSCWithin 6 months after enrollmentsDSC = (\|S(A) ∩ S(B)τ\| + \|S(B) ∩ S(A)τ\|) / (\|S(A)\| + \|S(B)\|), where S(A) and S(B) are the sets of points on the surfaces of A and B, S(B)τ represents the points on surface B that are within the tolerance τ of surface A, and S(A)τ represents the points on surface A that are within the tolerance τ of surface B. A represents the ground truth and B represents the manual, AI or AI-assisted delineation
Rate of time efficiency improvementWithin 6 months after enrollmentRate of efficiency time improvement= (manual contouring duration - AI-assisted contouring duration)/ manual contouring duration\*100%
Volumetric revision index, VRIWithin 6 months after enrollmentVRI = \[(A- A∩B) + (B- A∩B)\] /A, where A refers to the volume of the ground truth, and B refers to the volume of the manual, AI, or AI-assisted contour.
Recall, RecWithin 6 months after enrollmentRec = \| A∩B\| / A, where A refers to the volume of the ground truth, and B refers to the volume of the manual, AI, or AI-assisted contour.
Precision, PreWithin 6 months after enrollmentPre= \|A∩B\| / B, where A refers to the volume of the ground truth, and B refers to the volume of manual, AI, or AI-assisted contour.
Relative volume difference, RVDWithin 6 months after enrollmentRVD = \|A-B\| /A, where A refers to the volume of the ground truth, and B refers to the volume of the manual, AI, or AI-assisted contour.
Investigators satisfaction score for AI contouringWithin 6 months after enrollmentEvaluated on a 1-5 Likert scale: 1 - strongly dissatisfied, 2 - dissatisfied, 3 - neutral, 4 - satisfied, 5 - strongly satisfied.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORZhiyong Yuan, Ph.D.

Tianjin Medical University Cancer Institute and Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026