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Melanoma Detection by Oblique-Incidence Optical Spectroscopy

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Skin Cancer

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Trial Information

Melanoma Detection by Oblique-Incidence Optical Spectroscopy

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

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.

Inclusion Criteria:

1. 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

2. Patients who agree to participate and sign the informed consent

Exclusion Criteria:

1. Patients who do not have a suspicious skin lesion

2. Patients who have not signed the informed consent and have agreed to participate

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

4 Years

Safety Issue:


Principal Investigator

Madeleine Duvic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

January 2012

Related Keywords:

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



UT MD Anderson Cancer CenterHouston, Texas  77030