New breast cancer locator aims to reduce repeat surgeries
NCT ID NCT06461663
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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35 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Apr 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Agaplesion Markus Krankenhaus
Frankfurt, Germany
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Breast Unit Heidelberg, St Elisabeth Hospital
Heidelberg, Germany
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Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland
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Spital Zollikerberg
Zurich, Switzerland
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U.O. Senologia Ospedale Santa Chiara, Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
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U.O. Senologia, Instituto Clinico Humanitas
Milan, Italy
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