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Trial record 96 of 537 for:    "Skin cancer"

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
Sponsor:
Information provided by (Responsible Party):
Sung Hyun Pyun, Speclipse Australia Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Skin Cancer Device: Spectra-Scope Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Measurement using Spectra-Scope
Short pulsed Nd:YAG laser irradiation onto the skin lesion / measurement with Spectra-Scope
Device: 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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sung Hyun Pyun, Ph.D. 82-10-2227-4723 ceo@speclipse.com

Locations
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Australia, New South Wales
Integrated Specialist Healthcare Recruiting
Miranda, New South Wales, Australia, 2228
Contact: Nicholas Vasudeva    61447656384    nicholas.vasudeva@ishc.com.au   
Principal Investigator: Saleem Loghdey, M.D.         
Sponsors and Collaborators
Sung Hyun Pyun
Investigators
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Principal Investigator: Saleem Loghdey, M.D. Integrated Specialist Healthcare

Additional Information:
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Responsible Party: Sung Hyun Pyun, CEO, Speclipse Australia Pty Ltd
ClinicalTrials.gov Identifier: NCT03069846     History of Changes
Other Study ID Numbers: Speclipse-2016-10
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sung Hyun Pyun, Speclipse Australia Pty Ltd:
skin cancer
laser spectroscopy
non-invasive diagnostics

Additional relevant MeSH terms:
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Skin Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases