NCT00432471

Brief Summary

The goal of this clinical research study is to evaluate an experimental imaging technology, the multispectral digital microscope (MDM), which may help doctors see how far skin cancer extends (widens out) on an area of skin. Researchers want to learn if this new technology can help doctors identify the exact areas involved in precancerous or cancerous changes in the skin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 30, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

10.4 years

First QC Date

February 5, 2007

Last Update Submit

June 27, 2017

Conditions

Keywords

Skin CancerNon-Melanoma Skin CancerOptical ImagingMultispectral Digital Microscope SystemMDM

Outcome Measures

Primary Outcomes (1)

  • Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region

    4 Years

Study Arms (1)

Optical Imaging

EXPERIMENTAL

Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.

Procedure: Optical Imaging

Interventions

Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.

Optical Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will be undergoing surgery to remove a region of skin suspected of containing non-melanoma skin cancer will be eligible to participate in this study. The proposed resection should be equal or greater than 1 cm in diameter.
  • In addition, patients undergoing induction chemotherapy or biologic therapy prior to surgical resection are also eligible.
  • Patients must sign an informed consent indicating awareness of the investigational nature of this study.

You may not qualify if:

  • Patients with non-melanoma skin cancer lesion at eyelid, or in case that the lesion extends to superior or inferior eyelid, this area will not be imaged.
  • Persons who are medically unfit to undergo resection of skin lesions.
  • Persons under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Optical Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ann M. Gillenwater, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 7, 2007

Study Start

January 30, 2007

Primary Completion

June 25, 2017

Study Completion

June 25, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations