Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02470273 |
| Other study ID # |
DGA-0860 |
| Secondary ID |
Q141095 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2015 |
| Est. completion date |
May 11, 2021 |
Study information
| Verified date |
May 2023 |
| Source |
Rockefeller University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
