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Which technique best finds hidden breast tumors? large study puts localization methods to the test

NCT ID NCT05559411

Knowledge-focused Sponsor: European Breast Cancer Research Association of Surgical Trialists 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Surgeons use imaging-guided techniques to locate breast tumors they cannot feel, aiming to remove the cancer completely while sparing healthy tissue. This large observational study compares several methods, including wire-guided localization, intraoperative ultrasound, magnetic seeds, and radioactive seeds, to see which ones help achieve clear margins and avoid repeat operations. Researchers also track how comfortable each method feels for patients. The study follows thousands of women with non-palpable malignant breast lesions across multiple centers.

What this could mean

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

What this could lead to
If one localization method proves more reliable, hospitals could adopt it to reduce repeat surgeries and improve comfort for women with non-palpable breast tumors.
What could go wrong
This observational study cannot prove cause and effect, and results may reflect differences in surgeons or hospitals rather than the localization technique itself. Findings may not apply to all breast cancer types or treatment 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.

Participants

About 7,416 people

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

Started

Jan 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Female and male patients with invasive breast cancer or DCIS scheduled for breast-conserving surgery with an imaging-guided localization

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: * Signed informed consent form * Malignant breast lesion requiring breast-conserving surgery and imaging-guided localization (either DCIS or invasive breast cancer; multiple or bilateral lesions and the use of neoadjuvant chemotherapy are allowed) * Planned surgical removal of the lesion using one or more of the following imaging-guided localization techniques: * Wire-guided localization * Intraoperative ultrasound * Magnetic localization * Radioactive seed localization * Radioguided Occult Lesion Localization (ROLL) * Radar localization * Radiofrequency identification (RFID) tag localization * Ink/carbon localization * Female / male patients ≥ 18 years old Exclusion Criteria: * Patients not suitable for surgical treatment * Patients requiring mastectomy as first surgery * Surgical removal without imaging-guided localization

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ

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

  • University Hospital Schleswig-Holstein Campus Lübeck

    RECRUITING

    Lübeck, Germany

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