Cairn Surgical Publishes Clinical Trial Results Showing Lower Positive Margin Rates With Breast Cancer Locator System
Cairn Surgical, Inc., a medical technology company focused on improving the precision of breast cancer surgery, has announced the publication of results from its pivotal Breast Cancer Locator (BCL) Trial in the Annals of Surgical Oncology. The international clinical study evaluated the company’s investigational Breast Cancer Locator System against conventional wire localization in patients undergoing breast-conserving surgery. The findings showed lower observed positive surgical margin rates and fewer repeat surgeries among patients in the BCL group compared with those who received conventional wire localization.
The study’s results highlight the potential of three-dimensional, MRI-based surgical guidance to help surgeons remove breast tumors more precisely while preserving as much healthy breast tissue as possible. The findings may be particularly relevant for patients with certain breast cancer types that can be difficult to remove completely, including ductal carcinoma in situ (DCIS) and invasive lobular carcinoma (ILC).
According to the published results, the observed positive margin rate was 14% in the BCL group, compared with 21% in the conventional wire localization group. The observed re-excision rate, which measures how often patients require another operation to remove remaining cancer cells, was 13% in the BCL group and 20% in the wire localization group.
The study also reported lower positive margin rates with the BCL System across all analyzed patient subgroups. Among patients with DCIS, the observed positive margin rate was 21% in the BCL group, compared with 53% in the wire localization group. For patients with invasive lobular carcinoma, the rates were 9% and 26%, respectively.
The trial reported comparable safety profiles between the two groups. Cairn Surgical said the results support further evaluation of its technology as an approach to improving surgical guidance in breast-conserving surgery.
The Breast Cancer Locator System remains investigational in the United States and is limited by U.S. law to investigational use only.
International Randomized Trial Evaluates Surgical Guidance Technology
The BCL Trial was an international, prospective, multicenter, randomized controlled study designed to compare the effectiveness and safety of Cairn Surgical’s Breast Cancer Locator System with conventional wire localization.
The trial involved 418 patients with non-palpable, MRI-visualized invasive breast cancer or ductal carcinoma in situ. It was conducted across 23 clinical sites by 44 surgeons in the United States, Canada, the United Kingdom and Austria.
The study focused on patients whose tumors could not be readily identified through physical examination and required imaging-based guidance during surgery. In these cases, surgeons need reliable information about the location and extent of the cancer to plan the removal of the targeted tissue.
Conventional wire localization is an established technique used to guide surgeons toward non-palpable breast lesions. However, the technique generally provides a localized marker rather than a comprehensive three-dimensional representation of the tumor and its surrounding boundaries.
The BCL System is designed to address this limitation by using information from a patient’s MRI scan to help surgeons understand the tumor’s spatial dimensions and plan the intended resection volume.
By comparing the investigational system with conventional wire localization in a randomized clinical trial, researchers aimed to assess whether the additional spatial information could translate into differences in surgical outcomes.
The published results showed lower observed positive margin and re-excision rates in the BCL group. These findings provide clinical evidence for continued investigation of technologies designed to improve the precision of breast-conserving procedures.
Positive Surgical Margins Remain a Challenge in Breast-Conserving Surgery
Breast-conserving surgery is an important treatment option for many patients with breast cancer. The procedure aims to remove the cancerous tissue while preserving the remainder of the breast as much as possible. Achieving this balance requires surgeons to remove the tumor completely while avoiding unnecessary removal of surrounding healthy tissue.
One of the major challenges is ensuring that cancer cells do not remain at the edge of the removed tissue.
A positive surgical margin occurs when cancer cells are present at the edge of the excised tissue, indicating that the tumor may not have been completely removed. Depending on the clinical circumstances and pathology findings, a positive margin may require additional surgery to remove remaining cancer cells.
Such repeat procedures, commonly called re-excisions, can create additional challenges for patients and healthcare providers. Patients may need to undergo another operation, arrange further appointments and manage additional recovery time. Repeat surgery can also increase healthcare costs and contribute to uncertainty and anxiety during an already difficult period.
For healthcare systems, additional procedures require operating-room capacity, clinical staff time and other resources. Reducing the need for avoidable repeat surgery could therefore have implications for both patient experience and healthcare resource utilization.
Despite improvements in breast imaging and surgical techniques, positive margin rates remain a concern. Cairn Surgical noted that repeat surgery occurs in approximately 20% of patients undergoing breast-conserving surgery in the context described in its announcement, with rates potentially higher for certain challenging cancer types.
The BCL Trial examined whether a more detailed approach to identifying and targeting the tumor could help address this persistent problem.
Its results showed that patients treated with the investigational BCL System had a lower observed positive margin rate than patients treated with conventional wire localization.
Although the findings are encouraging, the clinical significance of any reduction must be considered in the context of the full study results, patient characteristics and the limitations associated with an investigational device.
How the Breast Cancer Locator System Works
The Breast Cancer Locator System is designed to help surgeons move beyond identifying the approximate center of a tumor toward defining a more precise three-dimensional target for tissue removal.
According to Cairn Surgical, the system combines two main components: an interactive three-dimensional visualization tool called the Visualizer and a patient-specific, three-dimensional-printed form.
The technology uses information derived from supine magnetic resonance imaging (MRI). Supine MRI refers to imaging performed while the patient is lying on their back, a position that more closely resembles the patient’s orientation during breast surgery than imaging performed in other positions.
This positioning can be important because the shape and position of breast tissue may change with body position. Information obtained from imaging can be more useful for surgical planning when it reflects the orientation in which the procedure will take place.
The Visualizer provides an interactive three-dimensional representation of the tumor. This is intended to help surgeons better understand the location, shape and spatial extent of the target tissue.
The patient-specific, three-dimensional-printed form is designed to support the placement of bracketing wires around the planned resection volume during surgery. These wires help indicate the boundaries of the tissue intended for removal.
Together, the components are intended to translate information from diagnostic MRI into practical guidance in the operating room.
Traditional localization techniques generally help identify where a lesion is located. The BCL System instead seeks to provide guidance about the volume of tissue that needs to be removed, taking into account the three-dimensional characteristics of the tumor.
This distinction may be particularly important for tumors that have irregular shapes or extend across tissue in ways that are difficult to represent with a single localization point.
The goal is to help surgeons make more informed decisions about the extent of tissue removal and potentially improve the likelihood of achieving clear margins during the initial procedure.
Study Shows Lower Observed Positive Margin Rates
One of the most significant findings reported from the BCL Trial was the difference in observed positive margin rates between the two study groups.
Among all randomized patients analyzed, the positive margin rate was 14% in the BCL group, compared with 21% in the conventional wire localization group.
This represents a seven-percentage-point difference between the groups.
The study also found that the observed re-excision rate was lower among patients treated using the BCL System. The rate was 13% in the BCL group, compared with 20% in the wire localization group.
Re-excision is an important outcome because it reflects the need for another operation following the initial breast-conserving procedure.
The lower observed rate in the BCL group suggests that more patients in that group completed the surgical process without requiring a second operation to address remaining cancer cells.
However, these results should be understood as the observed outcomes reported by the trial. They do not, by themselves, establish that every patient will experience the same benefit or that the technology will produce identical results across all clinical settings.
The trial’s randomized design and participation across multiple international centers provide a structured basis for comparing the two approaches. Further interpretation depends on the study’s full methodology, statistical analyses and clinical context.
Nevertheless, the reported differences offer a reason to continue examining the role of three-dimensional MRI-based guidance in breast-conserving surgery.
Potential Benefits for Patients With Challenging Breast Cancer Types
The study’s subgroup findings drew particular attention to patients with ductal carcinoma in situ and invasive lobular carcinoma.
These breast cancer types can present specific challenges when surgeons attempt to remove all affected tissue while preserving healthy breast tissue.
Ductal carcinoma in situ
Ductal carcinoma in situ is a condition in which abnormal cells are found within the milk ducts of the breast and have not invaded surrounding breast tissue. Although DCIS is non-invasive, treatment may involve surgery to remove the affected area and reduce the risk of progression or recurrence.
DCIS can extend through the ducts in patterns that make it difficult to determine the full extent of the affected tissue. This can complicate surgical planning and increase the challenge of obtaining clear margins.
In the BCL Trial, the observed positive margin rate among patients with DCIS was 21% in the BCL group, compared with 53% in the conventional wire localization group.
The difference suggests that more precise three-dimensional targeting may be worth further investigation for patients whose disease presents challenges in defining the appropriate resection volume.
Invasive lobular carcinoma
Invasive lobular carcinoma is a type of breast cancer that begins in the milk-producing lobules and can grow in patterns that make its extent difficult to determine through conventional assessment.
The tumor may not always form a clearly defined mass, potentially complicating efforts to identify the full area requiring removal.
Among patients with invasive lobular carcinoma, the trial reported an observed positive margin rate of 9% in the BCL group, compared with 26% in the wire localization group.
These findings indicate a lower observed positive margin rate among patients treated with the investigational system in this subgroup.
The results may be important because patients with challenging tumor patterns can face an increased likelihood of additional surgery. However, subgroup results should be interpreted carefully, and additional evidence may be needed to determine how consistently these differences can be reproduced across patient populations.
Comparable Safety Profiles Reported
In addition to evaluating surgical outcomes, the BCL Trial assessed the safety of the investigational system compared with conventional wire localization.
According to Cairn Surgical, the study found comparable safety profiles between the two groups.
Safety is a critical consideration when evaluating new surgical technologies. A system intended to improve surgical precision must also be assessed for potential risks associated with its use, including those related to planning, localization and the procedure itself.
The reported comparable safety profiles provide an important part of the overall findings. They suggest that the lower observed positive margin and re-excision rates in the BCL group were not accompanied by a reported overall difference in safety between the groups.
The full interpretation of safety findings depends on the specific adverse events recorded, their frequency and severity, and the duration of patient follow-up. The company’s announcement does not provide detailed event-level data, so further conclusions about individual safety outcomes should not be drawn from the summary alone.
The findings nevertheless contribute to the assessment of the BCL System as an investigational approach to surgical guidance.
Clinical Experts Highlight the Importance of Precision
Jennifer Gass, MD, Chief of Surgery at Women & Infants Hospital and Professor of Surgery and Obstetrics and Gynecology at The Warren Alpert Medical School of Brown University, served as Principal Investigator of the BCL Trial.
Gass highlighted the challenges associated with positive surgical margins and the additional procedures that can follow. She noted that repeat surgery can increase costs and make the treatment experience more difficult for patients, while positive margin rates have remained a persistent concern despite established guidelines.
She also emphasized that the study showed lower observed positive margin rates across all analyzed patient groups treated using the BCL System.
According to Gass, the findings suggest that providing surgeons with three-dimensional spatial guidance derived from supine MRI may offer the potential to improve patient outcomes, particularly for cancers such as DCIS and invasive lobular carcinoma that can be difficult to remove completely.
Her comments underscore the clinical rationale behind the technology: providing surgeons with a more complete understanding of tumor dimensions may help them plan and perform tissue removal more precisely.
The potential value of this approach is not limited to the technology itself. Its clinical impact depends on how imaging information is translated into surgical decisions and whether that information helps surgeons achieve appropriate margins without unnecessarily removing healthy tissue.
The BCL Trial provides comparative clinical data that can help inform continued evaluation of this approach.
Cairn Surgical Emphasizes Years of Clinical Development
David Danielsen, Chief Executive Officer of Cairn Surgical, said the publication reflects years of clinical development and collaboration involving surgeons and patients across four countries.
He described the trial results as evidence that a more precise approach to breast-conserving surgery has the potential to improve the experience of women undergoing breast cancer treatment.
For Cairn Surgical, publication in the Annals of Surgical Oncology represents an important milestone in communicating the clinical evidence behind the BCL System.
Peer-reviewed publication enables clinical researchers and healthcare professionals to examine study methods and results within the scientific literature. It also supports wider discussion of new approaches to surgical guidance and the evidence required before they can become part of routine care.
The international nature of the trial is another important aspect of the research. With 23 sites and 44 surgeons participating across the United States, Canada, the United Kingdom and Austria, the study evaluated the system in multiple clinical environments.
Such collaboration can provide useful information about the practical application of a technology across different institutions and surgical teams, although results from any trial must still be assessed in light of its design and patient population.
Advancing Precision in Breast-Conserving Surgery
The publication of the BCL Trial results highlights the ongoing effort to improve surgical precision through advanced imaging and patient-specific guidance.
Breast-conserving surgery requires surgeons to balance two important goals: removing the cancer completely and preserving as much healthy breast tissue as appropriate. Better information about tumor location and extent may help clinicians plan that balance more effectively.
The BCL System is designed to use three-dimensional MRI-derived information to help define the intended resection volume, rather than relying only on a marker indicating the approximate location of the lesion.
The trial’s reported findings showed a lower observed positive margin rate of 14% with the BCL System compared with 21% with conventional wire localization. The observed re-excision rate was also lower, at 13% compared with 20%.
The subgroup findings were particularly notable for DCIS and invasive lobular carcinoma, where the BCL group had lower observed positive margin rates than the wire localization group.
These results provide evidence supporting continued investigation of the system’s potential role in breast-conserving surgery. They also highlight the importance of evaluating new technologies through randomized clinical studies that assess both effectiveness and safety.
Cairn Surgical has emphasized that the BCL System remains investigational in the United States and is limited by U.S. law to investigational use only. Its availability for routine clinical use should therefore not be assumed based on the publication of the trial results.
As research into breast cancer surgery continues, technologies that help translate detailed imaging into practical surgical guidance may offer opportunities to improve treatment planning and reduce the burden of repeat procedures. The published BCL Trial findings add to this research effort by examining whether three-dimensional, MRI-based localization can improve observed surgical outcomes compared with conventional wire localization.
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