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Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)

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ClinicalTrials.gov Identifier: NCT02470273
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Oregon Health and Science University
University of California, Irvine
Skin and Cancer Associates
Information provided by (Responsible Party):
Daniel Gareau, Rockefeller University

Brief Summary:
The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.

Condition or disease
Melanoma

Detailed Description:

The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.

The scientific hypothesis is that the diagnostic mechanism for superficial melanoma is the light tissue interaction that occurs between the blue shifted wavelengths (i.e. blue light, ultra violet light) and the superficial epidermis while the mechanism for diagnosis of deeper melanoma (i.e. Breslow depth >0.5mm) is the light/tissue interaction that occurs between the red shifted light (i.e. red light, infrared light) and the portion of the pigmented lesion that lies within the dermis. These hypotheses were fueled by initial observations that the diagnostic sensitivity and specificity were wavelength dependent in a study that looked at only the red, green and blue wavelengths as available in traditional digital dermoscopy imaging. The initial finding was that of the multiple features analyzed, more features were statistically significant diagnostics in the blue channel but there were (a relative minority) other features that fared better in the red channel. It is hypothesized that the diagnostic features that did better in the red channel were features of deep melanin while the superficial regions, which should theoretically be atypical in ALL melanomas, were evident in the quantitative endpoint metrics generated from the blue channel.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multicenter Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
Study Start Date : August 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Dermatology patients
Patients with a suspicious skin lesion indicated for biopsy



Primary Outcome Measures :
  1. A comparison between gold standard histopathology screening results and mAID screening results [ Time Frame: Day 1 ]
    A comparison between the gold standard invasive biopsy diagnostic result (melanoma or nevus) and the diagnostic result produced by automated computer image processing that operates on the mAID-produced hyperspectral image. This diagnostic result is defined as the melanoma Q-score, which is the percent likelihood that this lesion is melanoma based on a previous computer-learning algorithm that utilized 53 unique malignancy metrics.


Secondary Outcome Measures :
  1. A comparison between gold standard histopathology screening results and analysis of the standard dermatoscope image. [ Time Frame: Day 1 ]
    A comparison between the gold standard invasive biopsy diagnostic result (melanoma or nevus) and the diagnostic result produced by automated computer image processing that operates on the standard dermatoscope image. This diagnostic result is defined as the melanoma Q-score, which is the percent likelihood that this lesion is melanoma based on a previous computer-learning algorithm that utilized 53 unique malignancy metrics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dermatology patients with a suspicious lesion that will be biopsied as standard of care
Criteria

Inclusion Criteria:

  • Participant has normal appearing skin and a suspicious pigmented lesion.

Exclusion Criteria:

  • Lesion near the eyes (due to safety)
  • Inaccessibility to lesion related to device: ears, toes, fingers, nailbeds, ankles, elbows, genitals
  • Self-reported history of photosensitivity
  • Self-reported history of vitiligo and/or other sun sensitive disease

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): NCT02470273


Contacts
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Contact: Daniel Gareau, PhD, MCR 2123277983 dgareau@rockefeller.edu
Contact: Donna Brassil 2123277886 dbrassil@rockefeller.edu

Locations
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United States, California
Beckman Laser Institute at University of California Irvine Recruiting
Irvine, California, United States, 92617
Contact: Kenneth Linden, MD         
Principal Investigator: Kenneth Linden, MD         
Sub-Investigator: Kristen Kelly, MD         
Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Kenneth Linden, MD         
Principal Investigator: Kenneth Linden, MD         
Sub-Investigator: Kristen Kelly, MD         
The University of California (Davis) Terminated
Sacramento, California, United States, 95816
United States, Florida
Skin and Cancer Associates Recruiting
Plantation, Florida, United States, 33324
Contact: Margaret Oliviero, NP    954-473-6750      
Principal Investigator: Harold Rabinovitz, MD         
United States, Oregon
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Eric Smith, MBA, MST       smiteric@ohsu.edu   
Contact: Loa Nowina-Sapinski       nowinasa@ohsu.edu   
Principal Investigator: Sancy Leachman, MD, PhD         
Sub-Investigator: Eric Simpson, MD         
Sponsors and Collaborators
Daniel Gareau
Oregon Health and Science University
University of California, Irvine
Skin and Cancer Associates
Investigators
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Principal Investigator: Daniel Gareau, PhD, MCR Rockefeller University

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Responsible Party: Daniel Gareau, Instructor in Clinical Investigation, Rockefeller University
ClinicalTrials.gov Identifier: NCT02470273     History of Changes
Other Study ID Numbers: DGA-0860
Q141095 ( Other Identifier: FDA )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Gareau, Rockefeller University:
Melanoma

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas