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New breast cancer locator aims to reduce repeat surgeries

NCT ID NCT06461663

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a custom-made device called the Breast Cancer Locator (BCL) in 35 women with non-palpable breast cancer. The device helps surgeons see exactly where the tumor is during breast-conserving surgery, with the goal of removing all cancer in one go and reducing the need for additional surgery. The study measured how often cancer cells were left behind and how much healthy tissue was removed.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

35 people

The number who actually took part.

Started

Jun 2022

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

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: * Patient Informed consent form (ICF) signed * Female Aged ≥ 18 years at the time of the signature of ICF * Histologic diagnosis of IBC or DCIS * Tumor excision that will require localization because it cannot be definitively defined by palpation * The tumor is unifocal; possible satellite lesions \< 2 cm from primary are eligible * The tumor enhances and is greater than or equal to 5mm on prone breast MRI imaging * Subject and surgeon agree to perform BCS * Willingness to follow all study procedures, including attending all site visits, tests and examinations. Exclusion Criteria: * Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes * Severe claustrophobia * Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy * Uncontrolled cardiac, renal, or pulmonary disease * Uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma) * Compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury * Pregnancy or breast-feeding * Subjects who have received or plan to receive neoadjuvant chemotherapy * Sternal notch to nipple distance of \> 32 cm as measured in a sitting or standing position * Measurement of widest circumference around breasts and arms \> 135 cm * Known allergy to device components * Multicentric tumors (additional tumors \> 2 cm from primary) * Infectious or inflammatory processes near the area of intervention * Planned surgery with localization devices including WGL, intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices * Simultaneous participation in an interventional study or participation in an interventional study in the last 1 month before study inclusion * Known drug and/or alcohol abuse * Mental incapacity that precludes adequate understanding or cooperation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Agaplesion Markus Krankenhaus

    Frankfurt, Germany

  • Breast Unit Heidelberg, St Elisabeth Hospital

    Heidelberg, Germany

  • Ospedale Regionale di Bellinzona e Valli

    Bellinzona, Switzerland

  • Spital Zollikerberg

    Zurich, Switzerland

  • U.O. Senologia Ospedale Santa Chiara, Azienda Ospedaliera Universitaria Pisana

    Pisa, Italy

  • U.O. Senologia, Instituto Clinico Humanitas

    Milan, Italy

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