Diagnosing Melanoma, Squamous Cell Carcinoma and Basal Cell Carcinoma Using the Spectra-Scope

NCT03069846 | Unknown DMC

• 1 other identifier: Speclipse-2016-10
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer

Keywords

skin cancer; laser spectroscopy; non-invasive diagnostics

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin.

  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.

  We plan to recruit 150 patients within a 3 month time frame.

Study Arms (1)

Measurement using Spectra-Scope

EXPERIMENTAL

Short pulsed Nd:YAG laser irradiation onto the skin lesion / measurement with Spectra-Scope

Device: Spectra-Scope

Interventions

Spectra-Scope DEVICE

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.

Measurement using Spectra-Scope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be aged 18 years or over;
• Have at least one suspicious lesion that:
• Is required to be biopsied for assessment of skin cancer (as assessed by at least one dermatologist);
• Has a diameter of more than 2 mm but less than 22 mm;
• Is accessible to the Spectra-Scope device;
• Provide written informed consent.

You may not qualify if:

• Have a known allergy to ethanol;
• Have a lesion that:
• Has previously been biopsied, excised or traumatised;
• Is not intact;
• Is within 1 cm of the eye;
• Is on a mucosal surface (lips, genitals);
• Is on palmar hands;
• Is on palmar feet;
• Is on or under nails;
• Is located on or in an area of visible scarring;
• Contains foreign matter (tattoo, splinter, marker)
• Have an active infection;
• Have an open lesion sampled;
• Have an autoimmune disease such as lupus or scleroderma vitiligo.

Sponsors & Collaborators

• Sung Hyun Pyun: lead

Study Sites (1)

Integrated Specialist Healthcare

Miranda, New South Wales, 2228, Australia

RECRUITING

Related Links

• International Conference of Harmonisation, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Dickson, P.V. and J.E. Gershenwald, Staging and prognosis of cutaneous melanoma. Surg Oncol Clin N Am, 2011. 20(1): p. 1-17.
• Rosado, B., Accuracy of Computer Diagnosis of Melanoma. Archives of Dermatology, 2003. 139(3): p. 361.
• Abbasi, N.R., et al., Early diagnosis of cutaneous melanoma: revisiting the ABCD criteria. JAMA, 2004. 292(22): p. 2771-6.
• ISO, Clinical investigation of medical devices for human subjects - good clinical practice. ISO 14155:2011 (E). 2011.

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Saleem Loghdey, M.D.

  Integrated Specialist Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Hyun Pyun, Ph.D.

CONTACT

82-10-2227-4723; ceo@speclipse.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 3, 2017
• Study Start: June 5, 2017
• Primary Completion: June 18, 2018
• Study Completion: June 18, 2018
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)