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Harmonics-based in Vivo Optical Virtual Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01980264
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 8, 2013
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Device: Harmonic generation optical biopsy

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Harmonics-based in Vivo Optical Virtual Biopsy
Study Start Date : January 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Diagnostic imaging Device: Harmonic generation optical biopsy


Outcome Measures

Primary Outcome Measures :
  1. Healthy volunteers of different skin colors and different ages [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Patients with suspected skin lesions [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Yi-Hua Liao, Doctoral 886-972651558 yihualiao@ntu.edu.tw

Locations
Taiwan
Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University Recruiting
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
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01980264     History of Changes
Other Study ID Numbers: 200903064D
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by National Taiwan University Hospital:
BD, AK

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell