Skin Cancer Clinical Trial
Official title:
Collecting Spectral Signatures of Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Benign Lesions and Normal Tissues Using Spectra-Scope
The primary objective is to collect emission spectra of normal tissue, pigmented normal lesion, benign lesion, SCC, BCC and melanoma to construct the database and validate the classifying algorithm.
The Speclipse Spectra-Scope consists of the light collection module and the spectral analysis
module. The light collection module is attached to the handpiece of short pulse (a few
nanoseconds) Nd:YAG (neodymium-doped yttrium aluminium garnet) commercial cosmetic laser, and
the analysis module is placed on the laser. When Nd:YAG laser is irradiated onto the skin
lesion, the laser ablates a trace amount of tissue, producing micro plasma. The emitted light
from the micro plasma is analysed spectrally to determine the elemental and molecular
information from the tissue in real time. No calibration of the Spectra-Scope is required.
Before the skin is irradiated with the laser, select the age, sex and the position of the
target skin lesion and put the patient number of the day on the software panel of laptop
which is connected to the device. Prior to sampling, the skin site must be wiped with ethanol
and allowed to air dry. When the laser is irradiated, the emission spectra of tissue is
automatically generated from the spectrometer inside the device and simultaneously displayed
on the monitor, and stored in the laptop. The spectral data stored in the laptop is
wirelessly accessible using Google drive.
An algorithm then determines whether the skin is from a normal, pigmented normal, benign,
squamous cell carcinoma (SCC), basal cell carcinoma (BCC) or melanoma based on the spectral
'signature'. These algorithms have been determined during clinical ex-vivo and in-vivo
studies performed in Korea. The purpose of this study is to collect tissue emission spectra
of Australian patients and to further refine the algorithms, and to confirm the appropriate
spectra for 'normal', 'benign', 'melanoma', 'SCC', and 'BCC'.
Each potential skin cancer site, which has previously been identified as requiring biopsy, is
assessed using five laser shots that last approximately 10 milliseconds per shot and
measurement. The laser shots are made before the scheduled biopsy.
Some of the potential skin cancer sites will be labelled as cancers ('melanoma', 'SCC' or
'BCC') from the biopsy result, and some of the potential skin cancer site will be labelled as
'benign' (control group 1) from the biopsy result.
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