Skin Cancer Clinical Trial
Official title:
Melanoma Detection by Oblique-Incidence Optical Spectroscopy
Verified date | January 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 490 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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