Harmonics-based in Vivo Optical Virtual Biopsy

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01980264
• Collaborator: National Health Research Institutes, Taiwan (Other)
• Enrollment: 500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 136.9
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin); Basal Cell Carcinoma; Squamous Cell Carcinoma	Device: Harmonic Generation Microscopy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Harmonics-based in Vivo Optical Virtual Biopsy
• Actual Study Start Date: Aug 5, 2009
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diagnostic imaging Harmonic Generation Microscopy	Device: Harmonic Generation Microscopy; Harmonic Generation Microscopy is a nonlinear optical microscopy.; Other Names: HGM

Outcome Measures

Primary Outcome Measures

1. Healthy volunteers of different skin colors and different ages [one year]

   Healthy volunteers of different skin colors and different ages

Secondary Outcome Measures

1. Patients with suspected skin lesions [one year]

   Patients with suspected skin lesions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University	Taipei		Taiwan	10002

Sponsors and Collaborators

• National Taiwan University Hospital
• National Health Research Institutes, Taiwan

Investigators

• Principal Investigator: Yi-Hua Liao, Doctoral, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• UFO-Lab

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT01980264
• Other Study ID Numbers: 200903064D
• First Posted: Nov 8, 2013
• Last Update Posted: Jan 23, 2020
• Last Verified: Jun 1, 2019

• Keywords provided by National Taiwan University Hospital: Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; BD, AK; melanin
• Additional relevant MeSH terms: Carcinoma; Melanoma; Carcinoma, Squamous Cell; Carcinoma, Basal Cell

Study Results

No Results Posted as of Jan 23, 2020