MedTrace Logo

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

NCT07527468 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DEVICE

Histolog® Scanner

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).

Sponsors & Collaborators

  • Hôpital du Valais

    lead OTHER

  • SamanTree Medical SA

    collaborator INDUSTRY

Principal Investigators

  • Colin Simonson, MD · Centre Hospitalier du Valais Romand (CHVR)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2030-03-01
Completion
2030-06-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07527468 on ClinicalTrials.gov