NCT00439205

Brief Summary

The goal of this clinical research study is to evaluate an imaging technology that may help clinicians see how far an area of pre-cancerous or cancerous tissue extends in the mouth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

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

February 7, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

10.7 years

First QC Date

February 21, 2007

Last Update Submit

October 18, 2017

Conditions

Oral Tumors

Keywords

Oral TumorsOral Margin SpectroscopyOral SpectroscopyOptical SpectroscopyOral neoplastic lesionsFastEEM4 SystemMultispectral Digital MicroscopeMDMNonstandard imaging technology

Outcome Measures

Primary Outcomes (1)

  • Feasibility of using optical imaging and spectroscopy to assist in margin detection for tumor resection in the oral cavity.

    3 Years

Study Arms (1)

MDM + FastEEM4

Multispectral digital microscope (MDM) + FastEEM4 Systems

Device: FastEEM4 SystemDevice: Multispectral Digital Microscope

Interventions

FastEEM4 SystemDEVICE

The FastEEM4 probe is moved toward the edge of the lesion(s) until it measures what appears to be normal mouth tissue.

MDM + FastEEM4
Multispectral Digital MicroscopeDEVICE

The MDM instrument will take pictures of abnormal-appearing and normal-appearing areas in the mouth.

Also known as: MDM
MDM + FastEEM4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with precancerous or cancerous oral lesions.

You may qualify if:

  • Patients with a lesion or history of a lesion of the oral mucosa.
  • Subjects with the ability and willingness to sign an informed consent and authorization.

You may not qualify if:

  • Persons who are medically unfit to undergo surgery.
  • 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

Biospecimen

Retention: SAMPLES WITH DNA

Tissue removal and study biopsies to be done so that researchers can better compare the appearance and diagnosis at these sites to the images that were taken.

Study Officials

  • Ann M. Gillenwater, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 23, 2007

Study Start

February 7, 2007

Primary Completion

October 10, 2017

Study Completion

October 10, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

US(1)