Clinical trial · Interventional
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
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)
NCT06461663CI-TRIAL-00112673completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Locator Guided Breast Conserving Surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with BCL
- description
- Subjects will undergo breast conserving surgery with the Breast Cancer Locator (BCL)
- interventionNames
- Device: Breast Cancer Locator Guided Breast Conserving Surgery
Primary outcomes (1)
- measure
- Positive Margin Rate
- timeFrame
- Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.
- description
- 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.
Secondary outcomes (4)
- measure
- Specimen Volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTThill 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. PMID 40478342