This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS).
After lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing.
Based on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.
Female patient, aged 18 years or older at time of surgery.
invasive lobular carcinoma (ILC/CLI),
pure ductal carcinoma in situ (DCIS), or
invasive carcinoma of non-special type (NST) with an associated DCIS component.
Pregnancy (confirmed or suspected) at time of surgery.
Prior neo-adjuvant treatment (hormonal therapy or chemotherapy) for the current breast cancer diagnosis.
Surgical indication for mastectomy rather than BCS.
Known hypersensitivity or allergy to acriflavine (fluorescent staining agent used with the Histolog Scanner).
Single group
Histolog® Scanner
DeviceCE-marked Class A IVD confocal fluorescence microscopy device (SamanTree Medical SA, Lausanne, Switzerland; UDI 764017998003GV; software v3.4.0). Used intraoperatively to image the surface of the fresh lumpectomy specimen ex vivo, without tissue processing or staining, providing real-time histological-quality margin assessment. Accessories: Histolog Dish (UDI 764017998004GX) and Histolog Dip fluorescent staining solution (UDI 764017998005GZ).
Reoperation Rate
Proportion of enrolled patients for whom the multidisciplinary tumour board recommends re-excision surgery following definitive histopathological analysis of the lumpectomy specimen. The outcome is binary (reoperation: yes/no). Compared against the historical institutional control rate of 11.3% (CHVR 2021-2024, n=266).
Reoperation rate
Proportion of patients requiring reoperation within each histological subgroup: (1) invasive lobular carcinoma (ILC), (2) pure ductal carcinoma in situ (DCIS), (3) invasive NST carcinoma with DCIS component (NST+DCIS).
Intraoperative recut rate
Proportion of cases requiring at least one intraoperative recut, with distinction between recuts indicated by standard of care versus recuts additionally indicated by Histolog Scanner findings. Localisation recorded (cranial, medial, caudal, lateral).
Cost analysis
Estimated cost differential between the prospective study group and the historical control group, accounting for the cost of reoperations avoided and the cost of Histolog Scanner use per procedure.
Concordance between intraoperative and final pathological margin assessment
Exploratory analysis of sensitivity and specificity of intraoperative Histolog Scanner margin assessment versus definitive histopathological margin status, where data are available for at least 80% of cases.
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Hôpital du Valais
Lead sponsor
SamanTree Medical SA
Collaborator
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