Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

AI-assisted contouring for breast cancer radiation treatment

Official title: LOCATOR - Locally Optimised Contouring With AI Technology for Radiotherapy

Run by Royal North Shore Hospital · NCT06546592 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment444 (estimated)
SponsorRoyal North Shore Hospital
Academic / other
Drugs / interventionsradiation
Locations3 sites (Dubbo, New South Wales and 2 other locations)
StatusRecruiting
StartedFebruary 11, 2025
Main results expectedFebruary 1, 2026
Study endsApril 30, 2030
Registry record updatedJanuary 29, 2026
Trial IDNCT06546592 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients under 18 years of age or those unable to understand consent documents may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using AI for contouring in radiation therapy, indicating a growing interest in this innovative approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.