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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00526032 |
Primary Objectives:
To develop and validate a diagnostic algorithm:
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:
Condition | Intervention |
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Skin Cancer |
Procedure: OIR Imaging |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Melanoma Detection by Oblique-Incidence Optical Spectroscopy |
Estimated Enrollment: | 1000 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Spectroscopic Oblique-Incidence Reflectometry (OIR)
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Procedure: OIR Imaging
Images from 4 different positions will be taken per lesion. The entire imaging procedure will take about 5 minutes per lesion.
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The OIR imaging probe is designed to reflect light in a special way in order to take pictures of pigmented skin.
As part of your standard of care, your physician will check all skin lesions that may possibly be cancerous or pre-cancerous. Your physician will also check any non-cancerous lesions that are being removed for cosmetic reasons, such as warts and freckles.
If you agree to take part in this study, the study doctor will decide which lesions will be biopsied, as well as which lesions are eligible to be imaged.
Pictures of the lesions (as well as healthy tissue nearby) will first be taken using a digital camera. The imaging probe and the area of the skin to be imaged will be cleaned with alcohol. After the imaging probe is placed over the lesion, a drop of baby oil will be applied to the skin. The imaging probe will then be lowered into contact with the skin, and the study staff will begin imaging. Twenty (20) images from 4 different positions will be taken per lesion.
Care will be taken to make sure that you cannot be identified from these images. For example, the study staff will avoid taking pictures of the face unless there are lesions there. After each lesion is imaged, the imaging device will be taken away and the skin surface cleaned. The entire imaging procedure, including preparation time, will take about 5 minutes per lesion.
Any hair on or around your lesions will be shaved or trimmed, if necessary. After all of the imaging is over, your lesion(s) will be biopsied. Your study doctor will decide which lesions require this kind of treatment as part of your standard care. Depending on what the study doctor decides, you will have either saucerization biopsies or excisional biopsies. A saucerization biopsy removes the entire lesion by cutting under it in a "scoop-like" manner. An excisional biopsy "cuts away" the entire lesion along with part of the surrounding skin.
A pathologist will receive your biopsied tissue and perform routine tests on the tissue. The test results will be available to the study doctor.
Depending on whether the results are negative or positive, you may be informed of the results, as the biopsies are standard of care.
The images of your skin will be used for research to try to make the imaging probe more effective.
If you end your participation in this study early, your photographs and information will be removed from the researchers' database at that time.
However, a record of your participation will remain in the database.
After all of the imaged lesions are biopsied, your participation in this study will be over.
This is an investigational study. The OIR imaging probe has not been approved by the FDA. Up to 1,000 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants having lesions on the skin that may be cancerous.
Inclusion Criteria:
Exclusion Criteria:
Contact: Madeleine Duvic, MD | 713-792-4578 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Madeleine Duvic, MD |
Principal Investigator: | Madeleine Duvic, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Madeleine Duvic, MD/Professor ) |
Study ID Numbers: | 2006-0564 |
Study First Received: | September 5, 2007 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00526032 History of Changes |
Health Authority: | United States: Institutional Review Board |
Skin Cancer Melanoma Detection Spectroscopic Oblique-Incidence Reflectometry OIR Imaging Probe |
Neuroectodermal Tumors Skin Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Skin Neoplasms Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Neuroendocrine Tumors Melanoma |