Ex-vivo confocal microscopy: diagnostic accuracy, acceptability & feasibility for skin cancers and inflammatory dermatoses
Ex-vivo confocal microscopy: diagnostic accuracy, acceptability & feasibility for skin cancers and inflammatory dermatoses in adults
Royal Prince Alfred Hospital
196 participants
Aug 23, 2023
Interventional
Conditions
Summary
SUMMARY Study title: Ex-vivo confocal microscopy: diagnostic accuracy, acceptability & feasibility This study is investigating the accuracy of a new method of analysing skin biopsies using a high-powered microscope to determine the diagnosis (for example, skin cancer, inflammatory skin condition) and whether the lesion is clear of the surgical margins or not. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have one or more skin lesions that need to be investigated and you are willing to have a biopsy (tissue sample) taken, when a biopsy is recommended for you as standard care by your treating doctor.. Study details All participants who choose to enrol in this study will not be asked to provide any extra skin samples that they would not already be providing as part of their standard clinical care. Participants who choose to enrol in this study would give permission for up to three of their skin biopsies to be examined with the new microscope. The skin biopsies will then undergo further preparation for scanning with the new fusion ex-vivo confocal microscope (fevCM) system and will also be assessed by the standard histology (staining of the tissue) analysis method. It is not anticipated that participation in this study will require additional time or travel commitments from patients. It is hoped this research will determine whether the new microscope method of assessing skin tissue is comparable to the standard assessment methods in terms of accuracy and time needed to prepare and analyse tissue samples. If the new microscope system is found to be accurate and quicker than the current assessment methods, use of this technology may be expanded to a greater number of patients.
Eligibility
Inclusion Criteria4
- Aged 18 years or older
- Have a clinician-identified lesion that is consistent with basal cell carcinoma ( BCC), squamous cell carcinoma (SCC), inflammatory dermatosis (including but not limited to dermatitis, psoriasis, rosacea, lichen planus, cutaneous lupus, etc.), or biopsy-proven lentigo maligna (LM) with a residual pigmented macule.
- Have a lesion needing biopsy or excision as per clinical evaluation, that is to be collected by punch biopsy, elliptical excision, excision with margin control or shave excision depending on the lesion itself
- Be willing and capable to provide informed consent and be willing to participate and comply with the study requirements.
Exclusion Criteria2
- Be unwilling or unable to provide informed consent or participate in the study
- Be deemed unsuitable by the treating clinician
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Interventions
This project aims to assess the performance of fusion ex-vivo confocal microscopy (fevCM) as a novel and cutting-edge imaging technology in the field of histological diagnosis. The instrument to be used in this study is the VivaScope® [MAVIG GmbH, Munich, Germany]. FevCM is a real-time technique that provides high-resolution digital images at the microscopic level of fresh tissue without causing any damage to the tissue. This allows for rapid diagnosis and/or margin assessment at the bedside or during a surgical procedure. This pilot study will assess the correlation of digital microscopic images obtained by fevCM with conventional pathology sections in keratinocyte cancers, melanocytic lesions and inflammatory dermatoses, to determine diagnostic accuracy (sensitivity, specificity, and predictive values). We will assess feasibility and user friendliness including through implementation outcomes, such as measurement of time required for fevCM and user acceptability for the clinician and pathologist. We also aim to describe disease-specific morphological features under fevCM visualization and correlate them with histopathology (hematoxylin-eosin) routine sections (frozen and paraffin). There may be one or more samples provided by each participant, depending on their number of lesions that are clinically suspicious for skin cancer and require biopsy or excision as part of their standard clinical care. Dermatologists with expertise in Mohs micrographic excision and/or confocal microscopy will analyse the specimens using fevCM; specialist histopathologists will then report on the specimens as per standard clinical care. FevCM examination of specimens for diagnostic confirmation can be done after participants have left the clinic; fevCM examination of specimens for margin control will take ~20 minutes per sample. Monitoring of adherence to the interventioncomprises the basis of this study (ie comparison of fevCM with standard histopathology).
Locations(1)
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ACTRN12623000629639