In vivo assessment of pigmented skin lesions by Raman spectroscopy

Melanoma is the most lethal form of skin cancer. Worldwide 200.000 patients are
diagnosed with melanoma each year and the incidence is increasing. Clinical
diagnosis of melanoma at an early stage is difficult even for the experienced
dermatologist. Assessments are generally based on visual inspection, with or
without tools such as dermoscopy. An objective, low-cost, easy-to-use tool is
needed to assist dermatologists and primary care physicians in making
assessments of pigmented skin lesions.The RASKIN project has started 2012 with
the ultimate goal to develop a low-cost, easy-to-use Raman-spectroscopic device
for use by dermatologists and primary care physicians, for objective, rapid
identification of pigmented skin lesions suspicious of melanoma. In this
project we have developed a pre-clinical device and used it to record an
extensive data set of over 300 pigmented skin lesions suspected of melanoma and
surgically excised for histopathological examination (ex vivo) at LUMC. This ex
vivo work has demonstrated that Raman spectroscopy has the potential to provide
an objective clinical tool to improve the clinical diagnostic accuracy of
pigmented skin lesions suspected of melanoma. The next necessary step is to
investigate the feasibility to perform the Raman measurements in vivo, directly
on the pigmenbted skin lesion, using a fiber-optic probe connected to the Raman
device.

Primary Objective: to explore the feasibility and to identify potential hurdles
of in vivo assessment of pigmented skin lesions by Raman spectroscopy.

Secondary Objective(s):
- to compare in vivo measurements with the results obtained by ex vivo
measurements on excised skin lesions suspicious of melanoma.
- to compare Raman spectra of suspicious lesions with benign lesions from the
same patient for reference.
- to validate the measurement protocol for in vivo assessment of suspicious
lesions within a clinical workflow.

Observational study. The study aims at exploring the feasibility of in vivo
application of the method, including identification of practical hurdles and
collection of a preliminary set of in vivo data.

To only risk associated with this study, harm to the eyes form the laser light
used for Raman measurements, is eliminated by wearing safety goggles. The
measurements are painless and will take at most 25 minutes. the results of the
Raman measurements do not impact on the diagnosis or treatment. In the context
of the study pigmented skin lesions that are surgically removed will be
examined by a second pathologist; if in rare cases the conclusion of
pathological examination would differ with respect to the diagnosis of
melanoma, pathological examination will be repeated at LUMC; if the conclusion
would be adapted by the clinical pathologist at LUMC after revision the patient
would be informed by the treating dermatologist.