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Imaging Device

Precision Optical Guidance for Mouth Sores

N/A
Recruiting
Led By Ann Gillenwater, MD
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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new imaging device to help doctors decide when to do an invasive biopsy of a mouth lesion.

Who is the study for?
This trial is for adults with visible mouth sores, like leukoplakia or erythroplakia, conditions that could turn into cancer, a history of oral cancer treatments, or diagnosed dysplasia. Participants must understand and sign consent forms. It's not for those allergic to proflavine, under 18, pregnant/nursing women, those unable to consent legally or prisoners.
What is being tested?
The study tests the Active Biopsy Guidance System using High Resolution Microendoscope (HRME), Optical Mapping Scope and Proflavine hemisulfate to see if it helps doctors better decide when and where to biopsy mouth lesions.
What are the potential side effects?
Potential side effects may include allergic reactions to Proflavine hemisulfate used during imaging. However, specific side effects related to the use of HRME and Optical Mapping Scope are not detailed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: The Active Biopsy Guidance SystemExperimental Treatment3 Interventions
This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,069 Previous Clinical Trials
1,802,594 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
307 Previous Clinical Trials
850,030 Total Patients Enrolled
Ann Gillenwater, MDPrincipal InvestigatorMD Anderson Caner Center

Media Library

High Resolution Microendoscope (HRME) (Imaging Device) Clinical Trial Eligibility Overview. Trial Name: NCT05554133 — N/A
Mouth Sore Research Study Groups: The Active Biopsy Guidance System
Mouth Sore Clinical Trial 2023: High Resolution Microendoscope (HRME) Highlights & Side Effects. Trial Name: NCT05554133 — N/A
High Resolution Microendoscope (HRME) (Imaging Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554133 — N/A
~13 spots leftby Mar 2025
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