New imaging device for guiding oral biopsies
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
This study is testing a new imaging device to help doctors decide when and where to do biopsies on mouth lesions to see if it works better than current methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05554133 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Active Biopsy Guidance System, a novel imaging device designed to assist doctors in determining the necessity and location for performing biopsies on oral lesions. The primary objective is to assess and enhance the technical performance of this system, while the secondary objective aims to estimate its sensitivity and specificity in relation to histopathology. The study involves the use of high-resolution microendoscopes and optical mapping scopes, along with a contrast agent called proflavine hemisulfate.
Who should consider this trial
Good fit: Ideal candidates include adults with clinically evident oral lesions or a history of oral cancer.
Not a fit: Patients who are under 18, pregnant, nursing, or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and less invasive biopsy procedures for patients with oral lesions.
How similar studies have performed: While this approach is innovative, similar studies using advanced imaging techniques have shown promise in improving biopsy accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Ability to understand and willingness to sign a written Informed Consent Document (ICD). Exclusion Criteria: 1. Known allergy to proflavine or acriflavine. 2. Age less than 18 years. 3. Pregnant or nursing females. 4. Adults unable to consent 5. Prisoners and other vulnerable populations
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ann Gillenwater, MD — MD Anderson Caner Center
- Study coordinator: Ann Gillenwater, MD
- Email: agillenw@mdanderson.org
- Phone: (713) 792-8841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.