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Multispectral + High-Resolution Microendoscopy for Oral Cancer
Phase < 1
Recruiting
Led By Ann 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at using different colors of light to get a better look at mouth lesions during surgery, which may help doctors better identify which ones are pre-cancerous or cancerous.
Who is the study for?
This trial is for adults with oral lesions who are already scheduled for surgery to remove or biopsy these areas. Participants must understand and be willing to sign a consent form. It's open to those who've had previous treatments.
What is being tested?
The study tests imaging techniques like wide-field and high-resolution in vivo imaging, using multispectral lights and proflavine dye, to better visualize mouth lesions during surgery and assess their cancer risk.
What are the potential side effects?
Potential side effects may include mild discomfort from the imaging process or reactions to the proflavine dye such as local irritation. However, detailed side effect profiles will depend on individual patient responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Classification of tissue
Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine.
Secondary study objectives
Percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye
Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (widefield multispectral imaging and HRME)Experimental Treatment3 Interventions
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proflavine
2015
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,864 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,404 Total Patients Enrolled
Ann GillenwaterPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult scheduled for surgery to remove or biopsy oral lesions.I am not participating in another clinical trial that involves treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (widefield multispectral imaging and HRME)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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