Diagnosing Melanoma, Squamous Cell Carcinoma and Basal Cell Carcinoma Using the Spectra-Scope
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|ClinicalTrials.gov Identifier: NCT03069846|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer||Device: Spectra-Scope||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Collecting Spectral Signatures of Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Benign Lesions and Normal Tissues Using Spectra-Scope|
|Actual Study Start Date :||June 5, 2017|
|Estimated Primary Completion Date :||June 18, 2018|
|Estimated Study Completion Date :||June 18, 2018|
Experimental: Measurement using Spectra-Scope
Short pulsed Nd:YAG laser irradiation onto the skin lesion / measurement with Spectra-Scope
The 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 Nd:YAG laser, and the analysis module is placed on the laser.
Each potential skin cancer site, which has previously been identified as requiring biopsy, should be assessed using five laser shots that last approximately 10 milliseconds per shot and measurement. The laser shots must be made before the scheduled biopsy.
All potentially cancerous lesions (or lesions that would usually undergo complete biopsy of the lesion or require follow up within three months) should be sampled. The Spectra-Scope will not provide a diagnosis at the time of sampling. Sites should record the spectra reported for each laser shot in the CRF.
- The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin. [ Time Frame: We plan to recruit 150 patients within a 3 month time frame. ]The aggregated emission spectra collected over a range of wavelengths from skin cells (skin cancer verses normal skin) irradiated with a commercial laser will be plotted to identify wavelengths with greatest spectra seperation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069846
|Contact: Sung Hyun Pyun, Ph.D.||email@example.com|
|Australia, New South Wales|
|Integrated Specialist Healthcare||Recruiting|
|Miranda, New South Wales, Australia, 2228|
|Contact: Nicholas Vasudeva 61447656384 firstname.lastname@example.org|
|Principal Investigator: Saleem Loghdey, M.D.|
|Principal Investigator:||Saleem Loghdey, M.D.||Integrated Specialist Healthcare|