HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery

NCT07527468 | Not Yet Recruiting

• 1 other identifier: HISMAR-CHVR-2025
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Ductal Carcinoma In Situ; Invasive Lobular Carcinoma; Breast Neoplasm Female

Keywords

breast-conserving surgery; lumpectomy; surgical margins; intraoperative imaging; confocal microscopy; reoperation; re-excision; histological scanning; DCIS; ILC; post-market performance follow-up; PMPF

Outcome Measures

Primary Outcomes (1)

• 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).

  Within 4 weeks after breast-conserving surgery

Secondary Outcomes (4)

• Reoperation rate

  Within 4 weeks after breast-conserving surgery

• Intraoperative recut rate

  Intraoperative

• Cost analysis

  At study completion, approximately 3.5 years

• Concordance between intraoperative and final pathological margin assessment

  Within 4 weeks after breast-conserving surgery

Study Arms (1)

Histolog® Scanner + Standard of Care

EXPERIMENTAL

Patients undergo breast-conserving surgery (BCS) with systematic intraoperative margin assessment using the Histolog® Scanner in addition to standard of care (palpation, specimen radiography at surgeon's discretion). Intraoperative recuts are decided based on combined standard of care and Histolog® Scanner findings. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology, independently of intraoperative findings.

Device: Histolog® Scanner

Interventions

Histolog® Scanner DEVICE

CE-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).

Also known as: Histolog Scanner

Histolog® Scanner + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• Incapacity to provide informed consent.
• Previous enrolment in this study.

Sponsors & Collaborators

• Hôpital du Valais: lead
• SamanTree Medical SA: collaborator

Study Sites (1)

Centre Hospitalier du Valais Romand (CHVR)

Sion, Valais, 1950, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Colin Simonson, MD

  Centre Hospitalier du Valais Romand (CHVR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Simonson, MD

CONTACT

+41276038331; Colin.simonson@hopitalvs.ch

Daniela Huber, Prof. MD

CONTACT

DanielaEmanuela.Huber@hopitalvs.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)