illumiSonics, a medical technology company commercialising label-free tissue imaging, has launched a prospective clinical validation study at Sunnybrook Health Sciences Centre evaluating its Multi-Laser Imaging (MLI) platform for skin cancer margin assessment during Mohs micrographic surgery.
The single-centre, prospective, observational study will enroll up to 200 patients undergoing Mohs surgery at Sunnybrook’s multidisciplinary dermatology clinic between July 2026 and December 2028. It is the first prospective clinical evaluation of MLI virtual histopathology, building on retrospective work in which the technique showed greater than 95% agreement with conventional histopathology for cancer type and 92% agreement for margin assessment, with pathologists unable to reliably distinguish MLI virtual slides from conventional chemically stained slides.
Mohs micrographic surgery is the gold standard for treating skin cancers in cosmetically and functionally sensitive areas such as the face (pictured), ears, nose, and hands. The procedure is performed in stages: tissue is removed, frozen, sectioned, stained, and examined under a microscope while the patient waits, with the cycle repeating until margins are confirmed clear. Each cycle of freezing, sectioning, staining, and review typically takes up to 60 minutes, and a multi-stage case can occupy most of a clinical day, contributing to throughput constraints and patient waiting lists that in some centres extend to several months.
MLI is illumiSonics’ proprietary imaging platform based on Photon Absorption Remote Sensing (PARS), a non-contact optical modality that captures high-resolution, label-free images of unstained tissue. In a single scan, MLI integrates six co-registered signals — four channels of hyperspectral autofluorescence, light scattering, and the PARS absorption signal — into a multi-dimensional dataset, from which machine learning can generate virtual H&E and other stains. Because the workflow is entirely digital and non-destructive, the tissue is preserved for any downstream testing that may be clinically indicated.
The study’s primary objective is to evaluate the diagnostic concordance of MLI-based virtual histopathology against standard-of-care frozen-section histopathology for skin cancer margin assessment. The primary endpoint is diagnostic agreement, measured by Cohen’s kappa, between MLI-based and standard-of-care interpretation by six masked board-certified pathologists. Secondary objectives include inter-rater reliability of margin assessment and the feasibility of integrating MLI into real-world clinical workflows.
The work will proceed in two sequential phases using only excess tissue that would otherwise be archived and discarded: Phase 1 images frozen tissue samples, and Phase 2 images fresh tissue prior to freezing. The study introduces no additional procedures for patients and does not affect their standard clinical care or treatment.
To learn more, visit www.INOVAIT.ca.