Trial record 5 of 5 for:    "Keratosis seborrheic"

Optical Biopsy of Human Skin in Conjunction With Laser Treatment

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540566
First received: October 4, 2007
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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
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: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Biopsy of Human Skin in Conjunction With Laser Treatment

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

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
skin temperature Device: OLCR,NIR/PMS,MI
OPTICAL SKIN BIOPSY

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

Inclusion Criteria:

  • Male or female age > 18 years

Exclusion Criteria:

  • current participation in any other investigational drug evaluation
  • inability to understand and carry out instructions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540566

Locations
United States, California
Beckman Laser Institute, Unversity of California Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: John S Nelson, M.D,Ph.D Beckman Laser Institue, University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540566     History of Changes
Other Study ID Numbers: RR-01192,AR-47551,HL-64218,
Study First Received: October 4, 2007
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Histiocytoma
Histiocytoma, Benign Fibrous
Carcinoma
Carcinoma, Basal Cell
Carcinoma, Merkel Cell
Carcinoma, Squamous Cell
Scleroderma, Systemic
Scleroderma, Diffuse
Hemangioma
Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
Melanoma
Nevus
Nevus, Pigmented
Sarcoma, Kaposi
Dysplastic Nevus Syndrome
Port-Wine Stain
Sarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Basal Cell
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on April 17, 2014