NCT06546592

Locally Optimised Contouring With AI Technology for Radiotherapy

LOCATOR - Locally Optimised Contouring With AI Technology for Radiotherapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

LOCATOR is a multicentre phase II randomised clinical trial that is looking at the process of contouring in radiation treatment for breast cancer patients. This study looks at whether contouring aided by artificial intelligence (AI) is comparable in quality to that of contouring done completely manually by a radiation oncologist. We are also looking at whether AI assisted contouring saves radiation oncologists time when compared to fully manual contouring. LOCATOR uses the LOCATOR software which is an in-house software developed locally and trained on local data.

Detailed description

LOCATOR is a multicentre phase II non-inferiority randomised controlled trial looking at comparing AI assisted contours (with in-house LOCATOR software) against fully manual contouring in breast cancer patients. The primary endpoint is to show non inferiority in grade of AI assisted contouring when compared to fully manual contouring with a poor contour (score \<= 2) as per the MD Anderson Contouring Grade Scale. Secondary endpoints include geometric assessments of contour accuracy, dosimetric differences based on contours, performance (geometric) when compared to commercially available tools as well as economic cost-benefit analysis if in-house AI contouring tools. The study will randomise patients 3:1 to the intervention arm of LOCATOR assisted contours to manual contours. An initial AI contouring model for each tumor type will be trained on contours from 45 previous breast cases using a nnUNetv2 framework. The model will then be iteratively updated every 20-50 patients.

Conditions

• Contouring
• Segmentation
• Radiation Therapy
• Artificial Intelligence
• Deep Learning

Interventions

Type	Name	Description
DEVICE	AI assisted contouring	Initial are generated automatically using software powered by artificial intelligence

Timeline

• Start date: 2025-02-11
• Primary completion: 2026-02-01
• Completion: 2030-04-30
• First posted: 2024-08-09
• Last updated: 2026-01-29

Locations

3 sites across 1 country: Australia