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Sponsors and Collaborators: |
University of California, Irvine Beckman Laser Institute University of California Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00540566 |
Purpose;
This study is to compare the ability of optical biopsy (where light enters the skin, is reflected back out, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination (where the pathologist looking at the piece of tissue through a microscope makes the diagnosis.) This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.
Hypothesis;
Photon Migration Spectroscopy (PMS) on each area of interest as identified by the physician. Photon Migration Spectroscopy is a non-invasive optical technique that utilizes intensity-modulated, near-infrared (NIR) light to quantitatively measure optical properties in thick tissues. Optical properties (absorption, µa, and scattering, µs', parameters) derived from PMS measurements shown low-resolution functional images of tissue hemoglobin (total, oxy, and deoxy forms), oxygen saturation, blood volume fraction, water content, fat content and cellular structure. PMS is currently employed in a number of other investigations including HS #1995-563 "Measurement of Breast tissue properties", HS#2002-2306 "Monitoring the response of chemotherapy on breast tumor" and HS#2004-3626 "Measurement of the Distribution of Optical Properties in Adult Human Muscle"
MI, multispectral imaging system operates by projecting low-power near-infrared structured light patterns on to the tissue of interest in a non-contact, reflection geometry and then capturing the reflectance with a CCD camera. The system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive 3D visualization of sub-surface structures. Moreover, while this system is low-resolution (~0.3mm) compared to OCT, it has a high sensitivity to functional parameters related to hydration and inflammation, making it complimentary to OCT.
The multispectral device uses a near-infrared tungsten-halogen bulb with heat filtering for tissue illumination, resulting in an optical power of <10mW/cm^2 in any 10nm band ranging from 600-1000nm. This is analogous to illumination with a bright flashlight, and will not inflict any pain or injury to the rat during the procedure. A CCD camera will capture the reflected light of various spatial illumination patterns over an area of 1cm^2 from a depth ranging from 0-4mm.
Condition | Intervention |
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Malignant Melanoma, Merkel Cell Carcinoma, Basal Cell Carcinoma, Squamous Cell Carcinoma Atypical Nevi, Congenital Nevi Seborrheic Keratosis, Paget's Disease Dermatofibroma, Kaposi's Sarcoma Hypervascular Congenital Malformations Port Wine Stain Hemangioma Tattoos Scleroderma Burns Normal Skin |
Device: OLCR,NIR/PMS,MI |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Optical Biopsy of Human Skin in Conjunction With Laser Treatment |
Enrollment: | 113 |
Study Start Date: | June 1999 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 |
Device: OLCR,NIR/PMS,MI
OPTICAL SKIN BIOPSY
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Procedure;
PMS,optical probe consisting of a pen shape plastic casing, optical fibers and a detector will be placed on the study skin.The unique functional information provided by PMS makes it well suited to characterizing vascular lesions and response to therapy. Measurements are performed using a non-invasive, multi-wavelength, diode-laser PMS device. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.
MI,multispectral device uses a near-infrared tungsten-halogen bulb with heat filtering for tissue illumination. This is analogous to illumination with a bright flashlight, and will not inflict any pain or injury to the rat during the procedure. A CCD camera will capture the reflected light of various spatial illumination patterns over an area of the study skin surface.The images will be taken before and after skin treatment.
Anticipate Risk and Benefit;
PMS:There are however, risks that are currently unforeseeable. The only item in contact with the skin is an pen shape optical probe. The optical powers we will use in this study are all far less than those used with surgical lasers. The measurement itself is painless, and there are no significant discomfort.
There are no benefit in this study. However,the knowledge gained from this study may be benefit for the future skin treatment
MI;There are no risks associated with the use of near infrared light. The light is gathered by a camera taking picture of the skin without contact the skin.
There are no benefit in this study. However,the knowledge gained from this study may be benefit for the future skin treatment
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
primary care clinic, community sample
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Beckman Laser Institute, Unversity of California Irvine | |
Irvine, California, United States, 92612 |
Principal Investigator: | John S Nelson, M.D,Ph.D | Beckman Laser Institue, University of California Irvine |
Responsible Party: | Beckman Laser Institute ( John S Nelson, M.D,Ph.D ) |
Study ID Numbers: | RR-01192,AR-47551,HL-64218,, STB-UC-98-84, DE-FG03-91ER61227, GM-58785, EB-00255, EB-02495, EB-00293, LMI-38445, NIH-LAMMP |
Study First Received: | October 4, 2007 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00540566 |
Health Authority: | United States: Institutional Review Board |
Burns Keratosis Carcinoma, Neuroendocrine Histiocytoma, Benign Fibrous Nevi flammei, familial multiple Squamous cell carcinoma Malignant mesenchymal tumor Port-Wine Stain Dermatofibroma Bone Diseases Soft tissue sarcomas Pagets disease Melanoma Neoplasms, Connective and Soft Tissue Kaposi sarcoma |
Musculoskeletal Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Osteitis Deformans Carcinoma, squamous cell Hemangioma Neuroepithelioma Neoplasms, Squamous Cell Congenital Abnormalities Skin Diseases Sarcoma, Kaposi Keratosis, Seborrheic Skin Abnormalities Carcinoma, Basal Cell Keratosis, seborrheic |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue |
Neoplasms, Basal Cell Nevi and Melanomas Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue |