Harmonics-based in Vivo Optical Virtual Biopsy
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|ClinicalTrials.gov Identifier: NCT01980264|
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Basal Cell Carcinoma Squamous Cell Carcinoma||Device: Harmonic Generation Microscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Harmonics-based in Vivo Optical Virtual Biopsy|
|Actual Study Start Date :||August 5, 2009|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Diagnostic imaging
Harmonic Generation Microscopy
Device: Harmonic Generation Microscopy
Harmonic Generation Microscopy is a nonlinear optical microscopy.
Other Name: HGM
- Healthy volunteers of different skin colors and different ages [ Time Frame: one year ]Healthy volunteers of different skin colors and different ages
- Patients with suspected skin lesions [ Time Frame: one year ]Patients with suspected skin lesions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980264
|Contact: Yi-Hua Liao, Doctoralfirstname.lastname@example.org|
|Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University||Recruiting|
|Taipei, Taiwan, 10002|
|Principal Investigator:||Yi-Hua Liao, Doctoral||National Taiwan University Hospital|