Melanoma Detection by Oblique-Incidence Optical Spectroscopy

NCT00526032 | Completed

• 1 other identifier: 2006-0564
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the adjacent normal skin for self-referencing. The experimental database will contain demographic information, clinical diagnoses, clinical images, OIR images, histopathologic diagnoses, and morphometric data on the lesions.
• To develop and validate a diagnostic algorithm:
• Classification: A subset (\~50%) of OIR images collected will be used to complete the development of state-of-the-art image processing algorithms to extract robustly effective diagnostic features.
• Blind Testing and Evaluation: The algorithms established will be evaluated and validated in a prospective blind-test fashion using the complementary subset of the database that was not involved in designing the classifier. The sensitivity and specificity of the classification system will be evaluated based on the receiver-operating-characteristic (ROC) curve.
• To identify the pathophysiologic parameters responsible for the diagnostic optical features: The anatomic and physiologic sources of the diagnostic optical signatures will be identified by comparative analyses using the OIR images, microscopic histomorphometric techniques and theoretical modeling to test the following hypotheses:
• The calculated differences in hemoglobin oxygen saturation.
• Comparisons of the calculated size distributions of skin scattering centers with histologic and morphometric analyses of various cellular and tissue components of the skin lesions.
• The relative densities and distributions of the different anatomic and physiologic diagnostic features within the interrogation volumes are important diagnostic factors in OIR.

Conditions

Skin Cancer

Keywords

Skin Cancer; Cancerous skin lesions; Melanoma Detection; Spectroscopic Oblique-Incidence Reflectometry; OIR Imaging Probe

Outcome Measures

Primary Outcomes (1)

• Test OIR diagnostic medical tool (imaging probe) designed for early detection of skin cancers

  Observational study where patients getting skin biopsies of suspicious pigmented lesions were asked if their moles could be imaged with incidence optical spectroscopy. The light that was reflected back out was analyzed and hypothesized to differ from normal skin.

  4 Years

Study Arms (1)

Spectroscopic Oblique-Incidence Reflectometry (OIR)

Procedure: OIR Imaging

Interventions

OIR Imaging PROCEDURE

Images from 4 different positions will be taken per lesion. The entire imaging procedure will take about 5 minutes per lesion.

Also known as: imaging probe

Spectroscopic Oblique-Incidence Reflectometry (OIR)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants having lesions on the skin that may be cancerous.

You may qualify if:

• Patients of any age, male or female, who are having a skin exam and are found to have a suspicious skin lesion on examination of their skin
• Patients who agree to participate and sign the informed consent

You may not qualify if:

• Patients who do not have a suspicious skin lesion
• Patients who have not signed the informed consent and have agreed to participate

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Madeleine Duvic, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 6, 2007
• Study Start: September 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

US (1)