Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Harmonics-based in Vivo Optical Virtual Biopsy

Summary: In our research, the investigators use the non-invasive 1230 nm ultra-fast laser as the light source, and utilize the non-linear light microscopic system to observe your skin. This microscopic system is successfully developed by the Graduate Institute of Photonics and Optoelectronics, National Taiwan University, and has not been commercialized yet. In the past, observations by this technology were performed on the skin of five subjects. The early stage of the skin clinical trial was approved by Research Ethics Committee of National Taiwan University Hospital. After the trial, the tested sites of subjects were evaluated by a dermatologist immediately, several hours, 24 hours, 3 days, and 1 week. There were no inflammatory symptoms, no skin color change, no pigmentation, no wound, no blister formation, and no ulceration reported. According to the subjects' experiences, they felt no discomfort during the experiment. After the experiment, there were no inflammatory symptoms and signs in the observed skin areas. Therefore, the preliminary trial showed that this technology is safe for the subjects.

Detailed description: The investigators invite you to join our experiment during January 2010 and December 2016. In our research, the investigators use the non-invasive 1230 nm Cr:Forsterite laser as the light source, and utilize the harmonic-generation light microscopic system to observe the skin of your forearm or the lesion. During the inspection process, please hold the skin area to be inspected on the supporting device, and a sucking disc before the microscope objective is adopted to stabilize the site to be observed. Near-infrared light with 1230 nm wavelength will be projected on your skin, and the reflected imaging signals are collected by the microscope. The investigators will expose the experimental skin area to the laser for no more than 30 minutes. The power of the laser the investigators use is limited within 1.5W (the power of an ordinary light bulb is 60-100W), and the total energy projected on the skin will be no more than 270J, which is equal to the total energy of a light bulb illuminating for 3-5 seconds. After the experiment, the investigators will examine your inspected skin area immediately. The entire process will be around one or two hours, including experiment explanation, laser exposure, and evaluation of health condition.
  If you are a patient with suspected melanoma, basal cell carcinoma, or squamous cell carcinoma, and already had skin biopsy or had tumor removed by surgery, without affecting pathological diagnosis and staging, the investigators will take 0.5x0.5x0.2cm3 chucks of tumor and surrounding normal skin from the specimen removed by surgery for observation of the harmonic-generation microscope. This process will not affect your following diagnosis and therapy.

Eligibility: Inclusion Criteria:
  1. healthy volunteers of different skin colors and different ages
  2. patients with suspected melanoma
  3. patients with suspected basal cell carcinoma or squamous cell carcinoma
  4. patients with diabetes mellitus
  Exclusion Criteria:
  1. volunteers have infectious disease
  2. volunteers' skin have been infected with ulceration

Relevance to patient case: not relevant