A Prospective Clinical Study Investigating the Use of the Histolog Scanner for Intraoperative Assessment of Surgical Margins in Patients Undergoing Breast-conserving Surgery for Histologically Confirmed Breast Cancer. The Histolog Scanner Operates on the Principle of Confocal Microscop

NCT07341542 | Not Yet Recruiting

• 1 other identifier: EK SNO 435/2026
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective clinical study investigating the use of the Histolog Scanner for intraoperative assessment of surgical margins in patients undergoing breast-conserving surgery for histologically confirmed breast cancer. The Histolog Scanner operates on the principle of confocal microscopy and enables non-destructive evaluation of specimen margins. The specimen will subsequently be sent for standard histopathological assessment; therefore, the use of this method does not pose any risk to the patient, as the diagnostic and therapeutic pathway for breast cancer will not be altered.

Conditions

Breast Cancer

Keywords

breast cancer; histolog scanner; surgical margins; breast-conserving surgery

Outcome Measures

Primary Outcomes (1)

• Reduction of reoperation rate (%)

  Intraoperative assessment of the surgical specimen using the Histolog Scanner in breast cancer patients undergoing breast-conserving surgery reduces the likelihood of reoperation for an R1 resection, i.e., tumor involvement at the surgical margin.

  4 months

Interventions

Histolog scanner DEVICE

The aim of the project is a prospective pilot evaluation in a cohort of 20 patients to determine whether the use of the Histolog Scanner may, in the future, reduce the number of reoperations by identifying positive surgical margins already during the initial procedure.The specimen will subsequently be sent for standard histopathological assessment; therefore, the use of this method does not pose any risk to the patient, as the diagnostic and therapeutic pathway for breast cancer will not be altered.

Eligibility Criteria

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

Study Population

Patients indicated for breast-conserving surgery in Silesian Hospital in Opava for breast cancer confirmed by core-cut biopsy.

You may qualify if:

• breast cancer confirmed by core-cut biopsy
• indication for breast-conserving surgery by a multidisciplinary team
• surgical therapy in Silesian Hospital in Opava during the study period

Sponsors & Collaborators

• Silesian Hospital in Opava: lead

Study Sites (1)

Silesian Hospital in Opava

Opava, Czechia

Location

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jan Žatecký, MD, PhD

CONTACT

+420776193203; janzatecky.jz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jan Žatecký, MD, PhD

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: January 20, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)