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Can AI deliver breast cancer radiation in a single session?

NCT ID NCT07776301

Disease control Sponsor: Fudan University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing a new, fully automated radiotherapy workflow for breast cancer, called 'all-in-one' or AIO. The approach uses artificial intelligence to plan and deliver radiation in a single, streamlined session, potentially reducing the time and steps involved in traditional treatment. The study will enroll 225 breast cancer patients who need radiotherapy, either before or after surgery, and will track side effects, treatment accuracy, and quality of life. The goal is to see if this one-stop method is safe and effective enough to become a standard option.

What this could mean

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

Active substance
An AI-guided, fully automated radiotherapy workflow that combines imaging, planning, and treatment in one session.
What this could lead to
If successful, this could make breast cancer radiotherapy faster, more precise, and less burdensome, potentially improving quality of life during treatment.
What could go wrong
The AI system may not always match human expert planning, and the trial is early, so results may not apply to all patients or settings.

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 225 people

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

Started

Aug 2021

Expected to finish

Nov 2028

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Histologically or pathologically confirmed breast cancer with definitive indications for radiotherapy (preoperative, postoperative, or radical) * ECOG performance status of 0-2 * Able to remain still and supine on the treatment couch for up to 30 minutes * Provision of signed, written informed consent * Able to comply with daily follow-ups and blood sample collections Exclusion Criteria: * Palliative radiotherapy for concurrent distant metastasis * Incomplete or ongoing chemotherapy * Synchronous multiple primary tumors * Current pregnancy or lactation * Prior history of radiotherapy to the ipsilateral breast, chest wall, thorax, or regional lymph nodes * Severe non-malignant comorbidities (e.g., cardiovascular or pulmonary diseases, systemic lupus erythematosus, scleroderma) resulting in a short life expectancy or inability to tolerate radical radiotherapy * Inability or unlikelihood to comply with study follow-up * Inability or unwillingness to provide written informed consent

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

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

  1. The places running it

    1 site. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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