Clinical Usefulness of Optical Skin Biopsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154921
First received: September 9, 2005
Last updated: November 22, 2005
Last verified: January 2004
  Purpose

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.


Condition Phase
Skin Neoplasms
Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Clinical Usefulness of Optical Skin Biopsy

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Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 30
Study Start Date: January 2004
Estimated Study Completion Date: December 2007
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Skin lesions admitted for surgical resection.

Exclusion Criteria:

  • none
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154921

Contacts
Contact: Wen-jeng Lee, M.D. jacklee@ntumc.org

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wen-jeng Lee, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Investigators
Study Director: Wen-jeng Lee, M.D. National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154921     History of Changes
Other Study ID Numbers: 9361700212, NTUH-94M29
Study First Received: September 9, 2005
Last Updated: November 22, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014