Skin Cancer Clinical Trial
Official title:
Melanoma Detection by Oblique-Incidence Optical Spectroscopy
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:
1. 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.
2. 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:
1. The calculated differences in hemoglobin oxygen saturation.
2. 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.
3. The relative densities and distributions of the different anatomic and physiologic
diagnostic features within the interrogation volumes are important diagnostic
factors in OIR.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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