Multispectral + High-Resolution Microendoscopy for Oral Cancer
Trial Summary
What is the purpose of this trial?
This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate in another clinical trial where you are actively receiving treatment while being part of this study.
What data supports the effectiveness of the treatment High-Resolution Microendoscopy for oral cancer?
High-resolution microendoscopy (HRME) has been shown to effectively distinguish between benign and cancerous tissues in various parts of the body, such as the upper aerodigestive tract and colorectal polyps, by providing real-time, detailed images of cell structures. This suggests it could be useful for identifying cancerous changes in oral tissues as well.12345
Is high-resolution microendoscopy safe for humans?
High-resolution microendoscopy (HRME) has been used safely in studies for various conditions, including head and neck cancer, colorectal polyps, and sinonasal pathology. The use of proflavine, a contrast agent, in these studies has not shown any significant safety concerns, indicating that HRME is generally safe for human use.12367
How does the treatment using Multispectral + High-Resolution Microendoscopy for Oral Cancer differ from other treatments?
This treatment is unique because it uses high-resolution microendoscopy (HRME) to provide real-time, non-invasive imaging of the mucosal surface, helping to distinguish between benign and cancerous tissues during surgery. This approach can improve the accuracy of identifying cancerous tissue and surgical margins compared to traditional methods, which are often more time-consuming and dependent on expert analysis.12348
Research Team
Ann M. Gillenwater
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with oral lesions who are already scheduled for surgery to remove or biopsy these areas. Participants must understand and be willing to sign a consent form. It's open to those who've had previous treatments.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging and Evaluation
Participants undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system at baseline, after induction of general anesthesia, and prior to surgery.
Follow-up
Participants are monitored for safety and effectiveness after imaging procedures
Treatment Details
Interventions
- High-Resolution Microendoscopy (Other)
- Multispectral Imaging (Other)
- Proflavine (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Dr. Peter WT Pisters
M.D. Anderson Cancer Center
Chief Executive Officer since 2017
MD from University of Western Ontario
Dr. Jeffrey E. Lee
M.D. Anderson Cancer Center
Chief Medical Officer
MD from Stanford University School of Medicine
National Cancer Institute (NCI)
Collaborator
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School