by Riku Togawa,
Johanna Hederer, Moira Ragazzi, Thomas Bruckner, Sarah Fastner, Christina
Gomez, André Hennigs, Juliane Nees, André Pfob, Fabian Riedel, Benedikt
Schäfgen, Anne Stieber, Michael P. Lux, Jörg Heil, Michael Golatta
The Breast: Published: February 22, 2023
Purpose
The Histolog®
Scanner (SamanTree Medical SA, Lausanne, Switzerland) is a large field-of-view
confocal laser scanning microscope designed to allow intraoperative margin
assessment by the production of histological images ready for assessment in the
operating room. We evaluated the feasibility and the performance of the
Histolog® Scanner (HS) to correctly identify infiltrated margins in clinical
practice of lumpectomy specimens. It was extrapolated if the utilization of the
HS has the potential to reduce infiltrated margins and therefore reduce
re-operation rates in patients undergoing breast conserving surgery (BCS) due
to a primarily diagnosed breast cancer including ductal carcinoma in situ.
Methods
This is a
single-center, prospective, non-interventional, diagnostic pilot study including
50 consecutive patients receiving BCS. The complete surface of the specimen was
scanned using the HS intraoperatively. The surgery and the intraoperative
margin assessment of the specimen was performed according to the clinical
routine consisting of conventional specimen radiography as well as the clinical
impression of the surgeon. Three surgeons and an experienced pathologist
assessed the scans produced by the HS for cancer cells on the surface. The
potential of the HS to correctly identify involved margins was compared to the
results of the conventional specimen radiography alone as well as the clinical
routine. The histopathological report served as the gold standard.
Results
50 specimens
corresponding to 300 surfaces were scanned by the HS. The mean sensitivity of
the surgeons to identify involved margins with the HS was
37.5% ± 5.6%, the specificity was 75.2% ± 13.0%. The
assessment of resection margins by the pathologist resulted in a sensitivity of
37.5% and a specificity of 81.0%, while the local clinical routine resulted in
a sensitivity of 37.5% and a specificity of 78.2%.
Conclusion
Acquisition of
high-resolution histological images using the HS was feasible in clinical
practice. Sensitivity and specificity were comparable to clinical routine. With
more specific training and experience on image interpretation and acquisition,
the HS may have the potential to enable more accuracy in the margin assessment
of BCS specimens.
