Breast CancerNCT06461663
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
A study testing Breast Cancer Locator Guided Breast Conserving Surgery in people with Breast Cancer, run by CairnSurgical, Inc. at 6 sites in 3 countries.
Trial summary
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Cancer Locator Guided Breast Conserving Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 22 Jun 2022to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany2 sites
Agaplesion Markus Krankenhaus
Frankfurt
Breast Unit Heidelberg, St Elisabeth Hospital
Heidelberg
Italy2 sites
U.O. Senologia, Instituto Clinico Humanitas
Milan
U.O. Senologia Ospedale Santa Chiara, Azienda Ospedaliera Universitaria Pisana
Pisa
Switzerland2 sites
Ospedale Regionale di Bellinzona e Valli
Bellinzona
Spital Zollikerberg
Zurich
About this study
Official title: An Interventional, Post-Market Study to Evaluate the Performance of a Custom-made Medical Device, "Breast Cancer Locator (BCL)" System, in Breast-conserving Surgery (BCS)
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.
Read the detailed description
The aim of this interventional, post-market, multicenter clinical investigation is to evaluate the performance of a custom-made medical device, the Breast Cancer Locator (BCL) system, in subjects with non-palpable breast cancer. The study will be conducted in European countries. To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained.
Each Subject, after signing an Informed Consent Form (ICF), will enter into a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) will be conducted.
At visit 1, the Subject will undergo supine MRI, from which a 3D breast image and BCL will be made.
At visit 2, the patient will undergo Breast Conserving Surgery (BCS) using the BCL system. On the same day, the specimen volume will be determined. The excised specimen will be sent to the pathological lab for analysis. The results, including the positive margin rate (PMR) and specimen mammogram, will be obtained within 14 days.
At visit 3, follow-up assessments (including physical examination, and adverse event review) will be performed.
At the End Of Study visit, adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q.
- Conditions
- Breast Cancer
- Being tested
- Breast Cancer Locator Guided Breast Conserving Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Locator Guided Breast Conserving SurgeryDevice
Subjects will undergo a contrast-enhanced supine MRI and two marks will be placed on the breast. The MRI images will be transmitted to the sponsor, and the images will be used to build a BCL using 3D printing. Investigators will be provided with a 3D image of the cancer in the breast. Investigators will use a BCL (a patient-specific, plastic, bra-like form that is placed on the breast and allows the investigator to mark the edges of the tumor on the skin and to place wires inside the breast which define the center of the cancer and the tumor edges. The surgeon will then attempt to surgically remove all the tissue inside the wires used to define the tumor edges.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BCL | Experimental | Subjects will undergo breast conserving surgery with the Breast Cancer Locator (BCL) Receives: Device: Breast Cancer Locator Guided Breast Conserving Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Margin Rate
To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL was obtained.
Measured: Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.
Secondary outcomes (4)
Specimen Volume
To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) was used.
Measured: Results obtained the same day of surgery.
Surgeon's Perception
To evaluate the surgeon's perception of the BCL system, a survey asking them if they strongly disagree, somewhat disagree, are undecided, somewhat agree, or strongly agree that the BCL made tumor localization easier, was easy to use, made tumor excision easier, and would be recommended by them, will be used.
Measured: Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery)
Number of Participants With Adverse Events
To evaluate the safety and tolerability of BCL, adverse events will be reported, including frequency, maximum intensity, relation to study treatment, seriousness, action taken, and outcome. Safety data will be handled descriptively.
Measured: From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Patient Satisfaction
To evaluate the patient's satisfaction, the BREAST-Q patient-reported outcome measure will be used. Patient satisfaction scores range from 0-100, with a higher score meaning greater satisfaction or better quality of life.
Measured: 6 weeks +/- 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start22 Jun 2022
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will undergo breast conserving surgery with the BCL.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CairnSurgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard J Barth, MD, Study director, Cairn Surgical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461663
- Sponsor's protocol ID
- CS-BCL-EU2021
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2023
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers.
Publications
Thill M, Ghilli M, Roncella M, Kelling K, Fansa H, Golatta M, Heil J, Haasteren V, Freitag A, Togawa R, Sagona A, Rooney TB, Fox MJ, Barth RJ Jr. A Multi-institutional Study to Evaluate the Effectiveness and Safety of a Supine MRI-Based Guidance System, the Breast Cancer LocatorTM, for Breast Conserving Surgery in Patients with Nonpalpable Breast Cancer. Ann Surg Oncol. 2025 Jun 6. doi: 10.1245/s10434-025-17513-4. Online ahead of print.
PubMed 40478342diFlorio-Alexander RM, Byrd B, Krishnaswamy V, Fox M, Paulsen K, Barth RJ Jr, Rooney T. Prone-to-Supine Breast MRI for Tumor Margin Visibility and Surgical Guidance. J Breast Imaging. 2026 Mar 27;8(2):178-189. doi: 10.1093/jbi/wbaf059.
PubMed 41686525
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Post-Market Study to Evaluate the Performance of a Custom-made Medical Device, "Breast Cancer Locator (BCL)" System, in Breast-conserving Surgery (BCS)
- ClinicalTrials.gov ID
- NCT06461663
- Acronym / sponsor ID
- CS-BCL-EU2021
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CairnSurgical, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.
Detailed description
The aim of this interventional, post-market, multicenter clinical investigation is to evaluate the performance of a custom-made medical device, the Breast Cancer Locator (BCL) system, in subjects with non-palpable breast cancer. The study will be conducted in European countries. To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained.
Each Subject, after signing an Informed Consent Form (ICF), will enter into a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) will be conducted.
At visit 1, the Subject will undergo supine MRI, from which a 3D breast image and BCL will be made.
At visit 2, the patient will undergo Breast Conserving Surgery (BCS) using the BCL system. On the same day, the specimen volume will be determined. The excised specimen will be sent to the pathological lab for analysis. The results, including the positive margin rate (PMR) and specimen mammogram, will be obtained within 14 days.
At visit 3, follow-up assessments (including physical examination, and adverse event review) will be performed.
At the End Of Study visit, adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will undergo breast conserving surgery with the BCL.
| Arm | Type | Receives |
|---|---|---|
| Treatment with BCL | Experimental | Device: Breast Cancer Locator Guided Breast Conserving SurgerySubjects will undergo breast conserving surgery with the Breast Cancer Locator (BCL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Cancer Locator Guided Breast Conserving SurgerySubjects will undergo a contrast-enhanced supine MRI and two marks will be placed on the breast. The MRI images will be transmitted to the sponsor, and the images will be used to build a BCL using 3D printing. Investigators will be provided with a 3D image of the cancer in the breast. Investigators will use a BCL (a patient-specific, plastic, bra-like form that is placed on the breast and allows the investigator to mark the edges of the tumor on the skin and to place wires inside the breast which define the center of the cancer and the tumor edges. The surgeon will then attempt to surgically remove all the tissue inside the wires used to define the tumor edges. | Device | Treatment with BCL |
Primary outcome
Positive Margin Rate
Time frame: Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.
To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL was obtained.
4 secondary outcomes
Specimen Volume
Time frame: Results obtained the same day of surgery.
Surgeon's Perception
Time frame: Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery)
Number of Participants With Adverse Events
Time frame: From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Patient Satisfaction
Time frame: 6 weeks +/- 7 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40478342Thill M, Ghilli M, Roncella M, Kelling K, Fansa H, Golatta M, Heil J, Haasteren V, Freitag A, Togawa R, Sagona A, Rooney TB, Fox MJ, Barth RJ Jr. A Multi-institutional Study to Evaluate the Effectiveness and Safety of a Supine MRI-Based Guidance System, the Breast Cancer LocatorTM, for Breast Conserving Surgery in Patients with Nonpalpable Breast Cancer. Ann Surg Oncol. 2025 Jun 6. doi: 10.1245/s10434-025-17513-4. Online ahead of print.
- Derived from this study: PubMed 41686525diFlorio-Alexander RM, Byrd B, Krishnaswamy V, Fox M, Paulsen K, Barth RJ Jr, Rooney T. Prone-to-Supine Breast MRI for Tumor Margin Visibility and Surgical Guidance. J Breast Imaging. 2026 Mar 27;8(2):178-189. doi: 10.1093/jbi/wbaf059.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Barth, MD study director
Cairn Surgical
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Cancer Locator Guided Breast Conserving Surgery in people with Breast Cancer, run by CairnSurgical, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Margin Rate (time frame: Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461663, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.