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Trial Title:
Precision Optical Guidance for Oral Biopsy
NCT ID:
NCT05554133
Condition:
Oral Lesions
Conditions: Official terms:
Proflavine
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
High Resolution Microendoscope (HRME)
Description:
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.
Arm group label:
The Active Biopsy Guidance System
Intervention type:
Device
Intervention name:
Optical Mapping Scope
Description:
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.
Arm group label:
The Active Biopsy Guidance System
Intervention type:
Drug
Intervention name:
Proflavine hemisulfate
Description:
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
Arm group label:
The Active Biopsy Guidance System
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).
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ann Gillenwater, MD
Phone:
713-792-8841
Email:
agillenw@mdanderson.org
Investigator:
Last name:
Ann Gillenwater, MD
Email:
Principal Investigator
Start date:
June 15, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Institute of Dental and Craniofacial Research (NIDCR)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05554133
http://www.mdanderson.org
