Clear margins guidance to detect microscopic cancer lesions during surgery
High-resolution confocal microscopy redesigned for operating room (OR) compatibility in multiple clinical workflows. DCIS, IDC, and ILC are at the fingertips of clinicians ² ⁻ ⁴.
The clinical need
There is no consensual intraoperative margin assessment (IOMA) technique in breast-conserving surgery. All current methods present particular benefits and disadvantages, mostly regarding accuracy and time required. Overall, where additional shaves are not systematically taken, about 20% of the patients need to undergo additional surgery ²˒³˒⁵˒⁶..
Needs to be met
In order to lower the rate of re-operation while ensuring the best outcome for the patient, a few prerequisites are absolute must-haves:
High-resolution to spot DCIS, IDC and ILC
Fast imaging that fits the OR pace and doesn’t require heavy specimen preparation
Easy-to-use approach for the clinician (no additional resources)
Our solution
The Histolog Scanner has been designed to fit seamlessly into the surgical workflow and help surgeons to ensure complete tumor removal at primary surgery.
The images can be easily analyzed after a short training by both surgeons or pathologists in the OR⁴, or sent to the pathology laboratory in a remote workflow.
Understand how the Histolog Scanner fits into your surgical workflow.
The Histolog images
Here is a preview of different types of tissues visualized with the Histolog Scanner. They can be easily recognized after a short training on our dedicated platform, the HIT Academy.
CLINICAL ROADMAP
Two initial studies were conducted in Germany to evaluate the effectiveness of the Histolog Scanner in detecting cancer in the intraoperative environment. The studies showed that the specificity was high, which ensured patient safety. The Polarhis study, in particular, revealed the potential of our approach by enabling up to a 75% potential reduction in re-operation rates².
An ambitious study that was running in parallel at Gustave Roussy Institute, which included 180 patients, further confirmed these promising results. The study showed that both surgeons and pathologists achieved a sensitivity and specificity of over 90% in detecting invasive (IDC, ILC) and in situ (DCIS) breast cancer lesions. These results further confirmed the potential of the Histolog Scanner as a game changer in breast conserving surgery⁴.
In light of these studies, the HIT Academy was developed as a training platform designed to support clinicians in reading Histolog Scanner images. With this advanced training, clinicians can now preserve as much healthy tissue as possible, without compromising on positive margins. The device has been integrated into multiple clinical workflows throughout Europe, enabling clinicians to improve patient outcomes and reduce the need for re-operation.
Key study : Comparison of breast cancer detection in surgical margins with standard-of-care
Prof. Dr. Med. Michael P. Lux, St. Vincenz Hospital, Germany
The Breast 2022
Superiority to standard-of-care (ultrasound + X-ray), potential reduction of re-operation up to 75%
Detection of DCIS on the surface and in-depth
Compatibility with clinical routine (2 min average usage per margin)
Case studies
