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Magnetic seeds vs. radioactive tracers: which better guides breast tumor removal?

NCT ID NCT05942118

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two modern, wire-free methods for locating non-palpable breast lesions before surgery: radioguided occult lesion localization (ROLL) using a radioactive tracer, and magnetic seed localization. The goal is to see which technique more reliably achieves clear surgical margins (no cancer cells at the edge of removed tissue) while minimizing excess tissue removal. The trial enrolls women with non-palpable, borderline or malignant breast lesions who are scheduled for breast-conserving surgery.

What this could mean

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

Active substance
Magnetic markers and radioactive tracer (ROLL)
What this could lead to
If one method proves superior, it could become the preferred standard for guiding breast-conserving surgery, reducing repeat procedures and improving patient comfort.
What could go wrong
This is a single-center study with 262 participants, so results may not apply broadly. Both techniques are already in use, so dramatic differences are unlikely.

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 262 people

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

Started

May 2023

Expected to finish

May 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 patients with non-palpable lesions candidated for surgery

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; * Non-palpable breast lesions; * Indication to lesion's surgical excision (lumpectomy, quadrantectomy) * Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5); * Written informed consent. Exclusion Criteria: * Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2); * Clinically palpable breast lesion; * Breast lesion localization for planned 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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