RecruitingACTRN12623000629639

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

Sponsor

Royal Prince Alfred Hospital

Enrollment

196 participants

Start Date

Aug 23, 2023

Study Type

Interventional

Conditions

inflammatory dermatoses

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a suspicious skin lesion is removed for analysis, it is currently processed through traditional laboratory methods — sliced, stained, and examined under a microscope by a pathologist. A new technology called ex-vivo confocal microscopy (fevCM) allows skin tissue to be scanned with a very high-powered laser microscope very quickly, producing detailed images without the time-consuming staining process. This could potentially speed up diagnosis and help surgeons know during the procedure whether a cancer has been fully removed. This study will compare the accuracy of this new microscope approach against the standard pathology method for diagnosing skin cancers (such as basal cell carcinoma, squamous cell carcinoma, and melanoma-related lesions) and inflammatory skin conditions. You may be eligible if you are 18 or older and have one or more skin lesions that your doctor recommends having biopsied or removed as part of your standard care. No extra skin samples beyond what your doctor already recommends will be taken. People who are unwilling to provide consent or are considered unsuitable by their treating clinician would not be eligible.

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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)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

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ACTRN12623000629639