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AI takes on tumor contouring: can it match the experts?

NCT ID NCT06546592

Knowledge-focused Sponsor: Royal North Shore Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares two ways of outlining tumors for breast cancer radiation: one done entirely by hand by a doctor, and one where artificial intelligence (AI) helps create the outline. The goal is to see if AI-assisted contouring is just as good and whether it saves time. About 444 breast cancer patients will take part across multiple hospitals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-assisted contouring software (device)
What this could lead to
If successful, this could show that AI can help radiation oncologists contour tumors faster and with similar quality, potentially improving efficiency in radiotherapy planning.
What could go wrong
This is a phase II trial, so results are still preliminary. The AI software is custom-built and may not work as well in other hospitals or for other cancer types. There is also a risk that AI-assisted contours may be less accurate than manual ones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 444 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Artificial intelligence Contouring Deep learning Radiation therapy Segmentation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central West Cancer Centre

    RECRUITING

    Orange, New South Wales, 2800, Australia

  • Department of Radiation Oncology, Royal North Shore Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Western Cancer Centre Dubbo

    RECRUITING

    Dubbo, New South Wales, 2830, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.