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Magnetic seeds vs radioactive dye: which is better for breast surgery?

NCT ID NCT05942092

Knowledge-focused Sponsor: Istituti Clinici Scientifici Maugeri SpA 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks back at 1,400 women who had breast-conserving surgery for non-palpable breast lesions. It compares two methods used to find the lesion during surgery: injecting a radioactive substance (ROLL) or placing a tiny magnetic seed. The goal is to see which technique leads to cleaner surgical margins and fewer repeat operations.

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 technique proves superior, it could guide surgeons toward a more effective method for removing non-palpable breast lesions with fewer repeat surgeries.
What could go wrong
This is a retrospective study, not a controlled trial, so results may be influenced by past decisions. It compares existing methods, not a new breakthrough.

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 1,400 people

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

Started

Apr 2023

Expected to finish

Sep 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

Breast cancer women with non-palpable lesions

Ages

18 to 85 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: * Female patients between 18 and 85 years who underwent to breast conservative surgery for non-palpable occult breast lesions; * Intraoperative localization of breast lesion with ROLL or magnetic seed; * Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5). Exclusion Criteria: * B2 or C2 at preoperative needle breast biopsy or fine needle breast aspiration. * Breast tumor localization with clip for neoadjuvant chemotherapy.

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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

Contacts and locations

Locations

  • Istituti Clinici Scientifici Maugeri SpA

    Pavia, Lombardy, 27100, Italy

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