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Could a simple ultrasound biopsy replace surgery for breast cancer staging?

NCT ID NCT07573657

Diagnosis Sponsor: The First Hospital of Jilin University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to see if a less invasive biopsy method, using ultrasound guidance, can accurately detect whether breast cancer has spread to nearby lymph nodes. Researchers will enroll 200 adults with newly diagnosed breast cancer. The goal is to find the best way to identify suspicious lymph nodes and confirm cancer spread with a needle biopsy, potentially avoiding more invasive surgery.

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 200 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 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.

Who is studied

Consecutive patients newly diagnosed with primary breast cancer and assessed for axillary lymph node metastasis by ultrasound, prospectively enrolled from November 2025 to November 2026 across multiple hospitals.

Ages

18 to 70 years

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. Age ≥18 years and \<70 years; 2. Histologically confirmed primary breast cancer; 3. Underwent ultrasound examination to assess axillary lymph node metastasis status. Exclusion Criteria: 1. Presence of other malignancies (e.g., lymphoma, lung cancer, thyroid cancer, etc., with axillary metastasis); 2. Pregnant or lactating women; 3. Previous receipt of neoadjuvant radiotherapy or chemotherapy; 4. Lymph node metastasis status not confirmed by pathology, or time interval between ultrasound examination and pathological confirmation exceeding 6 weeks.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Lymphatic Metastasis metastatic malignant neoplasm in the lymph nodes

As listed by the trial registrant

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

Breast neoplasms Lymphatic metastasis

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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