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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Silesian Hospital in Opava

Opava, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

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.

Primary outcomes

Reduction of reoperation rate (%)

Time frame: 4 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Žatecký, MD, PhD

CONTACT

[email protected]

+420776193203

Sponsors and collaborators

Lead sponsor

Silesian Hospital in Opava

Other

Registry information

Official study title

Assessment of Surgical Margins in Breast Cancer Patients Using the Histolog Scanner: A Pilot Prospective Study in the Czech Republic

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 14, 2026
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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