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AI reads MRI scans to predict who will benefit from chemo

NCT ID NCT07702708

Diagnosis Sponsor: Fujian Cancer Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests whether an artificial intelligence model can predict which patients with HR+/HER2- breast cancer will benefit most from chemotherapy given before surgery. Researchers will use pre-treatment MRI scans to classify patients into high- or low-benefit groups and compare their outcomes, such as residual cancer after treatment. The goal is to personalize chemotherapy decisions and avoid unnecessary treatment for those unlikely to respond.

What this could mean

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

Active substance
Pre-treatment DCE-MRI-based AI model
What this could lead to
If successful, this AI tool could help doctors identify which patients with HR+/HER2- breast cancer are most likely to benefit from chemotherapy before starting treatment, potentially sparing others from unnecessary side effects.
What could go wrong
This is an observational study, not a treatment trial, so it does not directly test a new therapy. The AI model's predictions need to be validated against historical data and may not improve outcomes in practice.

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.

Participants

About 100 people

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

Started

Jun 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

This study population consists of female patients aged 18 years or older with histologically confirmed stage II-III HR+/HER2-negative invasive breast cancer according to the 8th AJCC staging system. All participants receive routine standard neoadjuvant chemotherapy in multi-center breast cancer departments, complete standardized pre-treatment DCE-MRI with qualified imaging data, have ECOG performance status 0-1 and intact vital organ function. Subjects must satisfy all inclusion criteria, without meeting any exclusion criteria, and sign written informed consent voluntarily. Approximately 100 eligible patients will be consecutively enrolled from participating hospitals.

Ages

18 years and older

Sex

Female participants only

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: 1. Female patients aged ≥ 18 years old. 2. Histopathologically confirmed invasive breast carcinoma. 3. Hormone receptor positive (ER and/or PR ≥1%), HER2-negative status (IHC 0-1+, or IHC 2+ with negative FISH result). 4. Clinical stage II-III breast cancer per the 8th AJCC staging system, with clinical indication for neoadjuvant chemotherapy or primary surgery. 5. Standard pre-treatment breast DCE-MRI performed before neoadjuvant chemotherapy, with image quality eligible for AI model analysis. 6. ECOG performance status 0 or 1; adequate function of major vital organs to tolerate planned clinical treatment. 7. Voluntary participation with written informed consent obtained. Exclusion Criteria: 1. Prior systemic anti-tumor therapy for breast cancer other than planned neoadjuvant chemotherapy. 2. Inflammatory breast cancer or distant metastatic disease (M1). 3. Concurrent active malignant tumors of other origins. 4. Contraindications to MRI examination or unqualified MRI images that cannot support model analysis. 5. Severe comorbidities incompatible with neoadjuvant chemotherapy or surgical resection. 6. Any other conditions judged ineligible for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast neoplasms HR+ HER2- 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

    5 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

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fujian Provincial Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Ningde First Hospital

    RECRUITING

    Ningde, Ningde, China

  • Sanming Second Hospital

    RECRUITING

    Sanming, Sanming, China

  • The Second Affiliated Hospital of Fujian Medical University

    RECRUITING

    Quanzhou, Fujian, China

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