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Comparison Imaging System Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02473874
First Posted: June 17, 2015
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose

The purpose of this study is to obtain skin spectroscopic data from two imaging systems.

Comparison groups:

  • Skin Spect dermoscope
  • Spatially modulated quantitative spectrometer

Condition Intervention
Melanocytic Nevus Device: Skin Spect dermoscope Device: Spatially modulated quantitative

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Spectral Comparison Between Spatially Modulated Quantitative Spectroscopy and Polarization-Sensitive Hyperspectral Multimode Dermoscopy for the Purpose of Skin Compositional Analysis

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Changes in human skin structure [ Time Frame: up to 12 weeks ]
    Comparison Imaging Changes in human skin structure Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy


Estimated Enrollment: 30
Study Start Date: June 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Skin Spect dermoscope
Skin mole
Device: Skin Spect dermoscope
Skin imaging
Spatially modulated quantitative
Skin mole
Device: Spatially modulated quantitative
Skin imaging

Detailed Description:

The researcher can compare the spectroscopic data from the two systems as well as the relative concentrations of melanin, oxy- and deoxy- hemoglobin calculated from the measurements.

Skin Spect can measure larger area of skin, whereas Spatially modulated quantitative spectrometer is a point-based measurement.Therefore, larger nevi will require multiple Spatially modulated quantitative spectrometer measurements for comparison with corresponding sub-regions of the larger Skin Spect measurements. Only sub-regions of the image data from Skin Spect that match the locations Spatially modulated quantitative spectrometer acquired data will be used in this correlation study.

This researcher ensure that the spectral data collected by the two instruments are collected from the same spatial locations, should lesion heterogeneity be present.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from an outpatient population of subjects at Beckman Laser Medical Clinic, University of California, Irvine.
Criteria

Inclusion Criteria:

  • Skin lesion a mole located on flat surface of the body

Exclusion Criteria:

  • Mole located on complex surface
  • Pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473874


Contacts
Contact: Tyler Maly, MD 949.824.0606 tmaly@uci.edu

Locations
United States, California
Beckman Laser Institute Recruiting
Irvine, California, United States, 92612
Contact: Kristen Kelly, MD    949-824-7997    kmkelly@uci.edu   
Contact: Tyler Maly, MD    949.824.0606    tmaly@uci.edu   
Sub-Investigator: Anthony Durkin, PhD         
Sub-Investigator: Rolf Saager, PhD         
Principal Investigator: Kristen Kelly, MD         
Sub-Investigator: Tyler Maly, MD         
Sub-Investigator: Montana Compton, RN         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute, UCI
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Kristen Kelly, M.D., Professor of Dermatology and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02473874     History of Changes
Other Study ID Numbers: NIH-LAMPP-SBIR-2015-1791
First Submitted: June 5, 2015
First Posted: June 17, 2015
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Nevus, Pigmented
Nevus
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms