275 Participants Needed

Multispectral + High-Resolution Microendoscopy for Oral Cancer

AG
Overseen ByAnn Gillenwater
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 | MD Anderson Cancer ...

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

Ability to understand and the willingness to sign a written informed consent document (ICD)
I am an adult scheduled for surgery to remove or biopsy oral lesions.

Exclusion Criteria

I am not participating in another clinical trial that involves treatment.
Known allergy to proflavine or acriflavine
Pregnant or nursing females

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 day
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

3 months

Treatment Details

Interventions

  • High-Resolution Microendoscopy
  • Multispectral Imaging
  • Proflavine
Trial Overview The study tests imaging techniques like wide-field and high-resolution in vivo imaging, using multispectral lights and proflavine dye, to better visualize mouth lesions during surgery and assess their cancer risk.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Diagnostic (widefield multispectral imaging and HRME)Experimental Treatment3 Interventions
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

High-resolution microendoscopy (HRME) demonstrated a mean accuracy of 95.1% in distinguishing between benign and malignant mucosa in patients with squamous cell carcinoma, indicating its potential as a reliable diagnostic tool during surgery.
The technology showed high sensitivity (96%) and specificity (95%), making it effective for real-time intraoperative margin detection, which is crucial for ensuring complete removal of cancerous tissue.
Operative margin control with high-resolution optical microendoscopy for head and neck squamous cell carcinoma.Miles, BA., Patsias, A., Quang, T., et al.[2015]
High-resolution microendoscopy (HRME) using proflavine can effectively distinguish between sinonasal pathology and normal sinus epithelium, showing distinct imaging characteristics that could aid in real-time surgical margin differentiation.
While HRME performed well in identifying non-inflamed tissues, it struggled with inflamed tissues, indicating a need for improved imaging techniques or contrast agents to enhance accuracy in surgical settings.
Optical imaging with a high-resolution microendoscope to identify sinonasal pathology.Kidwai, SM., Parasher, AK., Schorn, VJ., et al.[2018]
High-resolution microendoscopy (HRME) significantly improves the ability to differentiate between neoplastic and non-neoplastic colorectal polyps, with diagnostic accuracy increasing from 63% to 96% as the endoscopist gains experience with the technique over 162 polyps.
The study shows that even endoscopists without prior HRME experience can achieve over 90% accuracy in identifying neoplastic polyps after imaging just 40 polyps, indicating HRME's potential as a valuable tool in colorectal cancer screening.
In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience.Parikh, ND., Perl, D., Lee, MH., et al.[2018]

References

Operative margin control with high-resolution optical microendoscopy for head and neck squamous cell carcinoma. [2015]
Optical imaging with a high-resolution microendoscope to identify sinonasal pathology. [2018]
In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience. [2018]
High-Resolution Optical Imaging of Benign and Malignant Mucosa in the Upper Aerodigestive Tract: An Atlas for Image-Guided Surgery. [2021]
In vivo diagnostic accuracy of high-resolution microendoscopy in differentiating neoplastic from non-neoplastic colorectal polyps: a prospective study. [2021]
High resolution microendoscopy for classification of colorectal polyps. [2013]
Optical imaging with a high-resolution microendoscope to identify cholesteatoma of the middle ear. [2021]
Discrimination of benign and neoplastic mucosa with a high-resolution microendoscope (HRME) in head and neck cancer. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security