Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526032
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2007-09-05
Brief Title:
Melanoma Detection by Oblique-Incidence Optical Spectroscopy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Melanoma Detection by Oblique-Incidence Optical Spectroscopy
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1000 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
To establish a statistically significant database With Spectroscopic Oblique-Incidence Reflectometry OIR experimental system we will obtain OIR spatio-spectral images of 1000 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
Detailed Description:
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 lesions 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 1000 patients will take part in this study All will be enrolled at M D Anderson
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 lesions 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 1000 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None