AI-assisted contouring for breast cancer radiation treatment
LOCATOR - Locally Optimised Contouring With AI Technology for Radiotherapy
NA · Royal North Shore Hospital · NCT06546592
This study is testing if using AI to help outline areas for radiation treatment in breast cancer patients is just as good and faster than having doctors do it by hand.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 444 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal North Shore Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 3 sites (Dubbo, New South Wales and 2 other locations) |
| Trial ID | NCT06546592 on ClinicalTrials.gov |
What this trial studies
LOCATOR is a multicentre phase II non-inferiority randomised controlled trial that compares AI-assisted contouring using in-house LOCATOR software to fully manual contouring by radiation oncologists for breast cancer patients. The study aims to determine if AI-assisted contouring is of comparable quality and whether it saves time for oncologists. Patients will be randomly assigned to receive either AI-assisted or manual contouring, with the primary endpoint focusing on the quality of the contours as assessed by the MD Anderson Contouring Grade Scale. Secondary endpoints include geometric accuracy, dosimetric differences, and a cost-benefit analysis of the AI contouring tool.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for treatment of primary breast malignancy and have an ECOG performance status of 0-2.
Not a fit: Patients under 18 years of age or those unable to understand consent documents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the efficiency and accuracy of radiation therapy for breast cancer patients.
How similar studies have performed: Other studies have shown promise in using AI for contouring in radiation therapy, indicating a growing interest in this innovative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dubbo, New South Wales and 2 other locations
- Western Cancer Centre Dubbo — Dubbo, New South Wales, Australia (RECRUITING)
- Central West Cancer Centre — Orange, New South Wales, Australia (RECRUITING)
- Department of Radiation Oncology, Royal North Shore Hospital — St Leonards, New South Wales, Australia (RECRUITING)
Study contacts
- Study coordinator: Joseph Chan, BSc MBBS PhD FRANZCR
- Email: joseph.chan@health.nsw.gov.au
- Phone: 94631300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Contouring, Segmentation, Radiation Therapy, Artificial Intelligence, Deep Learning