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

Sponsor
Hôpital du Valais
Study ID
NCT07527468
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

First listed
Apr 14, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
228 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Histolog® Scanner + Standard of Care
    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.

Primary Outcome Measure

Reoperation Rate [ Time Frame: Within 4 weeks after breast-conserving surgery ]

Central Contacts

Find similar trials

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials

Related Studies