NCT06546592

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Feb 2025Apr 2030

First Submitted

Initial submission to the registry

July 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

February 11, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Expected
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

July 25, 2024

Last Update Submit

January 27, 2026

Conditions

ContouringSegmentationRadiation TherapyArtificial IntelligenceDeep Learning

Keywords

ContouringSegmentationRadiation TherapyArtificial IntelligenceDeep Learning

Outcome Measures

Primary Outcomes (1)

  • Assessment of differences in Contour Quality

    To assess the contour quality of fully manual segmentation vs AI assisted segmentation. This assessment will be done using the MD Anderson Cancer Centre five-point likert scale used to validate autosegmentation models ranging from (Strongly disagree to Strongly Agree). The measure will be the proportion of unacceptable contours (as defined by MD Anderson autocontouring score \<= 2) between manual contouring and AI-assisted contouring.

    18 months

Secondary Outcomes (21)

  • Assessment of quality of AI assisted contours with and without manual edits

    18 months

  • Time Savings

    18 months

  • To assess the differences in acute clinician reported toxicity between patients treated with contours assisted by AI contouring versus manual contouring.

    18 months

  • To assess the differences in late clinician reported toxicity between patients treated with contours assisted by AI contouring versus manual contouring.

    5 years

  • To assess the differences in patient reported general acute quality of life outcomes between patients treated with contours assisted by AI contouring versus manual contouring.

    18 months

  • +16 more secondary outcomes

Study Arms (2)

AI assisted contouring

EXPERIMENTAL

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.

Device: AI assisted contouring

Manual contouring

NO INTERVENTION

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

Interventions

AI assisted contouringDEVICE

Initial are generated automatically using software powered by artificial intelligence

Also known as: autocontouring, autosegmentation, AI contouring
AI assisted contouring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Western Cancer Centre Dubbo

Dubbo, New South Wales, 2830, Australia

RECRUITING

Central West Cancer Centre

Orange, New South Wales, 2800, Australia

RECRUITING

Department of Radiation Oncology, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

Central Study Contacts

Joseph Chan, BSc MBBS PhD FRANZCR

CONTACT

94631300joseph.chan@health.nsw.gov.au

Heidi Tsang

CONTACT

94631300heidi.tsang@health.nsw.gov.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

August 9, 2024

Study Start

February 11, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

April 30, 2030

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)