Clinical trial NCT03069846: Diagnosing Melanoma, Squamous Cell Carcinoma and Basal Cell Carcinoma Using the Spectra-Scope
Official title: Collecting Spectral Signatures of Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Benign Lesions and Normal Tissues Using Spectra-Scope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Cancer
Keywords: skin cancer
laser spectroscopy
non-invasive diagnostics
Lead sponsor: Speclipse Australia Pty Ltd
Sponsor class: INDUSTRY
First posted: 2017-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Be aged 18 years or over;
2. Have at least one suspicious lesion that:

   1. Is required to be biopsied for assessment of skin cancer (as assessed by at least one dermatologist);
   2. Has a diameter of more than 2 mm but less than 22 mm;
   3. Is accessible to the Spectra-Scope device;
3. Provide written informed consent.

Exclusion Criteria:

1. Have a known allergy to ethanol;
2. Have a lesion that:

   1. Has previously been biopsied, excised or traumatised;
   2. Is not intact;
   3. Is within 1 cm of the eye;
   4. Is on a mucosal surface (lips, genitals);
   5. Is on palmar hands;
   6. Is on palmar feet;
   7. Is on or under nails;
   8. Is located on or in an area of visible scarring;
   9. Contains foreign matter (tattoo, splinter, marker)
3. Have an active infection;
4. Have an open lesion sampled;
5. Have an autoimmune disease such as lupus or scleroderma vitiligo.

Primary outcomes:
measure: The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin.
timeFrame: We plan to recruit 150 patients within a 3 month time frame.
Secondary outcomes:
Other outcomes:
Locations:
city: Miranda
country: Australia
facility: Integrated Specialist Healthcare
state: New South Wales
Study officials:
affiliation: Integrated Specialist Healthcare
name: Saleem Loghdey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: