What this study is
To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.
What's being tested
- High Resolution Microendoscope (HRME)
Intervention · DEVICE
The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification.
- Optical Mapping Scope
Intervention · DEVICE
The optical mapping scope displays a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures.
- Proflavine hemisulfate
Intervention · DRUG
A coloring substance (a fluorescent dye which glows green in the dark), called proflavine hemisulfate, will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures
Study details
- Official title
- Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Oral Lesions
- Enrolling
- 90 people
- Starts
- 2023-06-15
- Est. completion
- 2027-03-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.
- Ability to understand and willingness to sign a written Informed Consent Document (ICD).
You can't join if
- Known allergy to proflavine or acriflavine.
- Age less than 18 years.
- Pregnant or nursing females.
- Adults unable to consent
- Prisoners and other vulnerable populations
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openM D Anderson Cancer Center
Houston, Texas, United States
- Ann Gillenwater, MD · Contact713-792-8841agillenw@mdanderson.org
- Ann Gillenwater, MD · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2020-1115
Principal investigator
Ann Gillenwater, MD
MD Anderson Caner Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.