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Fluorescent Imaging for Premalignant Oral Lesions

N/A
Waitlist Available
Led By Ann M Gillenwater
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease
Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial is examining if using fluorescent imaging, spectroscopy, and tissue samples can help detect oral cancer earlier.

Who is the study for?
This trial is for adults at high risk of developing oral cancer, including those with conditions like lichen planus, Fanconi anemia, heavy tobacco use, or premalignant lesions in the mouth. It's also open to patients with a history of head and neck cancer but currently show no signs of disease.Check my eligibility
What is being tested?
The study tests imaging techniques that detect light emitted from tissues (fluorescence) to monitor for early signs of oral cancer. This includes taking pictures inside the mouth using special lights and cameras, as well as examining tissue samples under a microscope.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than drug treatments, side effects are minimal but may include discomfort from the imaging equipment or during sample collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had head or neck cancer or precancerous oral conditions but currently show no signs of disease.
Select...
I have a precancerous lesion in my mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lesions diagnosed via non-invasive brush cytology
Lesions diagnosed via point spectroscopy system
Lesions diagnosed via wide-field fluorescence imaging

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (fluorescent/reflectance imaging, spectroscopy)Experimental Treatment5 Interventions
Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorescence Spectroscopy
1999
N/A
~390
Diagnostic Microscopy
2017
Completed Early Phase 1
~90
Fluorescence Imaging
2014
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,464 Total Patients Enrolled
2 Trials studying Oral Tumors
70 Patients Enrolled for Oral Tumors
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,329 Total Patients Enrolled
Ann M GillenwaterPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the recruitment efforts for this trial still in progress?

"Clinicaltrials.gov's records show that this particular investigation is not currently enrolling participants, with the initial posting of August 27th 2007 and last editing on June 29th 2022. Even so, there are still 238 other studies looking for volunteers."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
2007. "Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00542373.
All > Fanconi Anemia > Lichen Planus
~19 spots leftby Apr 2025
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