Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
Condition: Melanoma
MeSH terms: Melanoma
Study type: Observational

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.
    

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
      
Keywords: Melanoma