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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 through study completion an average of 1 year.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~through study completion an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biopsy

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
2,973 Previous Clinical Trials
1,789,256 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,254 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

Frequently Asked Questions

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

Are there any still vacancies for volunteers in this clinical investigation?

"According to clinicaltrials.gov, this medical study is not actively seeking patients at the present moment - it was initially posted on March 1st 2023 and its last update occurred on September 21st 2022. Although this trial has ceased recruitment for now, there are still other trials that require participants."

Answered by AI

Who else is applying?

What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have suffered with SEVERE mouth sores for a long time. I have tried many prescription medications and probably every over the counter medication.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Not sure what next step is. Will you contact me or?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Precision Optical Guidance for Oral Biopsy
2023. "Precision Optical Guidance for Oral Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05554133.
~47 spots leftby Mar 2025
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