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

NCT ID: NCT07341542

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Histolog 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Silesian Hospital in Opava

OTHER

Sponsor Role lead

Responsible Party

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Jan Žatecký

Jan Žatecký, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Silesian Hospital in Opava

Opava, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Jan Žatecký, MD, PhD

Role: CONTACT

+420776193203

Other Identifiers

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EK SNO 435/2026

Identifier Type: -

Identifier Source: org_study_id

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