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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology
Study Overview
Brief Summary
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.
Detailed Description
Primary objective:
-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.
Secondary objective:
-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •Known allergy to proflavine or acriflavine.
- •Age less than 18 years.
- •Pregnant or nursing females.
- •Adults unable to consent
- •Prisoners and other vulnerable populations
Arms & Interventions
The Active Biopsy Guidance System
This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
Intervention: Proflavine hemisulfate (Drug)
The Active Biopsy Guidance System
This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
Intervention: High Resolution Microendoscope (HRME) (Device)
The Active Biopsy Guidance System
This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
Intervention: Optical Mapping Scope (Device)
Outcomes
Primary Outcomes
To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology
Time Frame: Through study completion an average of 1 year.
Secondary Outcomes
No secondary outcomes reported