Locally Optimised Contouring With AI Technology for Radiotherapy (LOCATOR)

Royal North Shore Hospital

Status: Enrolling

Conditions: Radiation Therapy; Deep Learning; Segmentation; Artificial Intelligence; Contouring

Treatments: Device: AI assisted contouring

Study type: Interventional

Funder types: Other

Identifiers

NCT06546592

2024/PID01401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 444 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years and older who are planned for primary breast malignancy
• ECOG performance 0-2
• Ability to understand and willingness to sign a written informed consent document
• The target volume must be able to be objectively reviewed by current published national or international clinical guidelines

Exclusion criteria

• Patients under 18 years of age
• Patients unable to understand consent documents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

444 participants in 2 patient groups

AI assisted contouring

Experimental group

Description:

Patients in this arm will have their contours/segmentations generated by a combination of the LOCATOR (AI) software before manual edits and checks by a radiation oncologist.

Treatment:

Device: AI assisted contouring

Manual contouring

No Intervention group

Description:

Patients in this arm will have standard of care which is fully manual contours/segmentations generated and checked by a radiation oncologist.