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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07341542

Enrollment

Registered

2026-01-14

Start date

2026-01-20

Completion date

2026-11-01

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

DEVICEHistolog scanner

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

* 0

Design outcomes

Primary

Measure	Time frame	Description
Reduction of reoperation rate (%)	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.

Countries

Czechia

Contacts

Primary ContactJan Žatecký, MD, PhD

janzatecky.jz@gmail.com+420776193203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026