Clinical trial NCT02470273: Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
Official title: Multicenter Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Melanoma
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: University of California, Irvine
name: Skin and Cancer Associates
First posted: 2015-06-12
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dermatology patients with a suspicious lesion that will be biopsied as standard of care

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.

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.

Eligibility 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

Primary outcomes:
measure: A comparison between gold standard histopathology screening results and mAID screening results
timeFrame: Day 1
Secondary outcomes:
measure: A comparison between gold standard histopathology screening results and analysis of the standard dermatoscope image.
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute at University of California Irvine
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: The University of California (Davis)
state: California
city: Plantation
country: United States
facility: Skin and Cancer Associates
state: Florida
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Rockefeller University
name: Daniel Gareau, PhD, MCR
role: PRINCIPAL_INVESTIGATOR
References: