Spectral Diagnosis of Cutaneous Malignancy

NCT00476905 | Completed

• 1 other identifier: 2006-0856
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.

Conditions

Skin Cancer

Keywords

Basal Cell Carcinoma; Squamous Cell Carcinoma; Pre-Cancer Lesions; Pigmented Lesions; Benign Lesions; Skin Cancer; Spectral Diagnosis; Optical Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Spectroscopic features of skin lesions in vivo

  Preparing lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion.

Study Arms (1)

Spectral-Diagnosis

Method for noninvasive detection of cutaneous malignancies

Device: Spectral Diagnosis Probe

Interventions

Spectral Diagnosis Probe DEVICE

The device collects two types of tissue spectra: i) laser-induced fluorescence spectra and ii) white light reflectance spectra. This portable reflectance spectrofluorimeter collects spectra in a fraction of a second. Light collection and delivery are achieved via an optical fiber probe. The optical fiber probe is approximately 1 mm in diameter and 3 m long. The same probe collects light emitted from the tissue and delivers it back to the instrument for spectral analysis.

Also known as: Optical Spectroscopy

Spectral-Diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients, at routine skin examination, found to have a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions, which may also warrant biopsy.

You may qualify if:

• Male or Female and over 18 years of age.
• Patients undergoing an examination of their skin
• Patients with a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions
• Patients whose lesion also warrants a biopsy.
• Signed informed consent document.

You may not qualify if:

• Patients with absence of skin lesion(s) in one of the five categories.
• Patients whose identified lesion did not need a biopsy.
• Patients who did not sign the informed consent and agree to participate.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• University of Texas at Austin: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Interventions

Spectrum Analysis, Raman

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Scattering, Radiation; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis

Study Officials

• Michael Migden, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: April 1, 2007
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

US (1)