Harmonics-based in Vivo Optical Virtual Biopsy

August 19, 2024 updated by: National Taiwan University Hospital
The research aims to study the molecules and structures in human skin by the image formation of harmonic-based in vivo optical virtual biopsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the research, the investigators use the Cr:forsterite laser as the light source, and utilize the nonlinear optical microscopic system to observe human skin via in vivo detection. In this study, images of human skin tissue will be acquired by virtual section to truly evaluate the feasibility of this system in clinical application.

This research intends to conduct the following research:

  1. To study the feasibility of this technology to observe melanin in the skin: As melanin is THG-bright, the technology will help to explore the distribution and change of melanin in the skin.
  2. To study the capability of this technology in the early diagnosis of skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma: By obtaining skin images of healthy and diseased patients, we can establish an image database of normal and cancerous skin in different atages, and evaluate the efficacy of this technology for early diagnosis of skin malignancy in the future.
  3. To study the ability of this technology to observe and analyze the degree of skin aging: Optical sectioning of human skin in a non-invasive in vivo manner can be used to detect the microscopic changes of skin aging and solar damage, and to find out the indicators of skin aging, so as to be used in the future to assist the therapeutic analysis of anti-skin aging treatment.
  4. To study the ability of this technology to observe peripheral vasculopathy and molecular changes of microvascular structures in diabetic patients: Perform microscopic imaging on healthy and diabetes patients' skin to observe effects of structures and molecules in their skin, such as peripheral vasculopathy in diabetic patients, and the status of disease parameters, with a view to find the cause of peripheral vascular lesions and other biological information.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To noninvasively provide real-time imaging of cutaneous histopathology and molecular changes.
Time Frame: one year
To observe some analyzed molecule (melanin density, HbA1c density, collagen density, etc) & structure (cell size, cell height, height of rete ridges, layer thickness, etc) parameters for different skin types & age groups. (the information above can be observed in the nonlinear images) (Cell or molecule density is defined as the cell or molecule numbers in the specific image area) (Structure can be observed and reconstructed via multiple z-depth images)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To provide a diagnostic tool for diseases.
Time Frame: one year
To diagnose if the analyzed pathological-related parameters (the parameters can be observed in the nonlinear images) (the pathological-related information includes cell shape, cell size, and molecular distribution (ex: chromatin, HbA1c, etc) in each single cell, etc) from Harmonic-based in Vivo Optical Virtual Biopsy can distinguish melanoma, basal cell carcinoma, squamous cell carcinoma, high & low HbA1c groups from control.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Health Research Institutes, Taiwan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2009

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 3, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimated)

November 8, 2013

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200903064D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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