Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06546592

LOCATOR - Locally Optimised Contouring With AI Technology for Radiotherapy

Led by Royal North Shore Hospital · Updated on 2026-01-29

444

Participants Needed

3

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the use of artificial intelligence (AI) to assist in contouring during radiation treatment for breast cancer patients. The trial compares AI-assisted contouring using the in-house LOCATOR software with fully manual contouring done by radiation oncologists. The study aims to evaluate whether AI-assisted contouring matches the quality of manual contouring and whether it can save oncologists time. It is a multicenter, phase II randomized controlled trial focusing on contour quality and efficiency. Participants are randomly assigned in a 3:1 ratio to either AI-assisted contouring or manual contouring groups. The AI model is initially trained on data from previous breast cancer cases and is updated regularly as more patients participate. In the AI-assisted group, contours are generated by the LOCATOR software and then manually reviewed and adjusted by oncologists. The manual group receives the standard care with contours created entirely by oncologists. During the study, researchers assess contour quality using the MD Anderson Contouring Grade Scale and various geometric and dosimetric measures. They also evaluate time savings, clinician-reported toxicity, patient-reported quality of life, and economic costs. Follow-up includes acute and late toxicity and quality of life assessments over 18 months to 5 years. Participant involvement includes contouring procedures, toxicity monitoring, questionnaires, and outcome evaluations over the study period.

CONDITIONS

Brief Title

Locally Optimised Contouring With AI Technology for Radiotherapy

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years and older who are planned for primary breast malignancy
  • ECOG performance status between 0 and 2
  • Ability to understand and willingness to sign a written informed consent document
  • Target volume must be reviewable by current national or international clinical guidelines
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 18 months

Participants receive contouring for radiotherapy either with AI-assisted software followed by manual edits or fully manual contouring by a radiation oncologist.

Visits scheduled as part of radiotherapy planning and treatment

Follow-up

Duration - Up to 5 years

Participants are monitored for acute and late toxicity, quality of life, and accuracy of contouring over time after treatment.

Periodic follow-up visits to assess health outcomes and quality of life

Trial Site Locations

Total: 3 locations

1

Western Cancer Centre Dubbo

Dubbo, New South Wales, Australia, 2830

Actively Recruiting

2

Central West Cancer Centre

Orange, New South Wales, Australia, 2800

Actively Recruiting

3

Department of Radiation Oncology, Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Actively Recruiting

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Research Team

J

Joseph Chan, BSc MBBS PhD FRANZCR

H

Heidi Tsang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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