NCT00154921

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 23, 2005

Status Verified

January 1, 2004

First QC Date

September 9, 2005

Last Update Submit

November 22, 2005

Conditions

Skin Neoplasms

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Skin lesions admitted for surgical resection.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wen-jeng Lee, M.D.

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Wen-jeng Lee, M.D.

CONTACT

jacklee@ntumc.org

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

January 1, 2004

Study Completion

December 1, 2007

Last Updated

November 23, 2005

Record last verified: 2004-01

Locations

TW(1)