Clinical Usefulness of Optical Skin Biopsy

Skin Neoplasms Clinical Trial

Official title:

Clinical Usefulness of Optical Skin Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00154921
• Other study ID #: 9361700212
• Secondary ID: NTUH-94M29
• Status: Recruiting
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: November 22, 2005
• Start date: January 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2004
• Source: National Taiwan University Hospital
• Contact: Wen-jeng Lee, M.D.
• Email: jacklee[@]ntumc.org
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Traditional biopsy requires the removal, fixation, and staining of tissues from the human body. Its procedure is invasive and painful. Non-invasive in vivo optical biopsy is thus required, which should provide non-invasive, highly penetrative, three-dimensional (3D) imaging with sub-micron spatial resolution. Optical biopsy based on scanning two-photon fluorescence microscopy (TPFM) is a good method for biopsy of skin due to its high lateral resolution, low out-of-focus damage, and intrinsic three-dimensional (3D) section capability. However current technology still presents several limitations including low penetration depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required. We study the harmonics optical biopsy of a human skin sample using a femtosecond Cr:forsterite laser centered at 1230 nm. Higher harmonics generation is known to leave no energy deposition to the interacted matters due to their energy-conservation characteristic. This energy-conservation characteristic provides the “noninvasive” nature desirable for clinical imaging. In our study, we will evaluate the clinical applications of optical skin biopsy using harmonic generation microscopy.

Description:

Traditional biopsy requires the removal, fixation, and staining of tissues from the human body. Its procedure is invasive and painful. Non-invasive in vivo optical biopsy is thus required, which should provide non-invasive, highly penetrative, three-dimensional (3D) imaging with sub-micron spatial resolution. Optical biopsy based on scanning two-photon fluorescence microscopy (TPFM) is a good method for biopsy of skin due to its high lateral resolution, low out-of-focus damage, and intrinsic three-dimensional (3D) section capability. However current technology still presents several limitations including low penetration depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required. We study the harmonics optical biopsy of a human skin sample using a femtosecond Cr:forsterite laser centered at 1230 nm. Higher harmonics generation is known to leave no energy deposition to the interacted matters due to their energy-conservation characteristic. This energy-conservation characteristic provides the “noninvasive” nature desirable for clinical imaging. In our study, we will evaluate the clinical applications of optical skin biopsy using harmonic generation microscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Skin lesions admitted for surgical resection.

Exclusion Criteria:

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Skin Neoplasms

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan,