Assessment of Surgical Margins in Breast Cancer Patients Using the Histolog Scanner: A Pilot Prospective Study in the Czech Republic
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Silesian Hospital in Opava
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Reduction of reoperation rate (%)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jan Žatecký
Jan Žatecký, MD, PhD
Silesian Hospital in Opava