Multispectral + High-Resolution Microendoscopy for Oral Cancer

Overseen By Ann Gillenwater

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergy to proflavine, acriflavine, pregnant, nursing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

275 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 3 4 8}

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

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

Group I: Diagnostic (widefield multispectral imaging and HRME) Experimental Treatment 3 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience. Parikh, ND., Perl, D., Lee, MH., et al.[2018]

High-resolution microendoscopy (HRME) enables real-time, non-invasive imaging of the upper aerodigestive tract, allowing for effective differentiation between benign and malignant tissues based on their nuclear organization and cellular architecture.

The study provides a comprehensive image collection that highlights unique imaging characteristics of various mucosal types, which can aid in accurate intraoperative diagnosis and early cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Resolution Optical Imaging of Benign and Malignant Mucosa in the Upper Aerodigestive Tract: An Atlas for Image-Guided Surgery. Levy, LL., Vila, PM., Park, RW., et al.[2021]

High-resolution microendoscopy (HRME) demonstrated a significantly higher diagnostic accuracy (94%) for differentiating neoplastic from non-neoplastic colorectal polyps compared to high-definition white-light endoscopy (WLE), which had an accuracy of only 65%.

HRME outperformed WLE particularly for small polyps (less than 10 mm), achieving an accuracy of 95% and a specificity of 98%, indicating its potential as a reliable tool for real-time polyp classification during colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo diagnostic accuracy of high-resolution microendoscopy in differentiating neoplastic from non-neoplastic colorectal polyps: a prospective study. Parikh, ND., Perl, D., Lee, MH., et al.[2021]

High resolution microendoscopy (HRME) allows for effective differentiation between neoplastic and non-neoplastic polyps during colonoscopy, achieving an overall accuracy of 85% across expert and novice observers.

The study established new HRME criteria for classifying colorectal mucosa, demonstrating that while expert microendoscopists had a sensitivity of 67% and specificity of 97%, novice users also performed well with a sensitivity of 73% and specificity of 91%, indicating that HRME can be effectively used even by less experienced practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High resolution microendoscopy for classification of colorectal polyps. Chang, SS., Shukla, R., Polydorides, AD., et al.[2013]

High-resolution optical imaging using proflavine can effectively distinguish between cholesteatoma and normal middle ear epithelium by highlighting the unique characteristics of keratin, which appears as hyperfluorescent areas without nuclei.

This imaging technique may improve surgical outcomes by enabling real-time identification of residual cholesteatoma, potentially leading to more complete removal of the disease during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical imaging with a high-resolution microendoscope to identify cholesteatoma of the middle ear. Levy, LL., Jiang, N., Smouha, E., et al.[2021]

In a study involving 38 patients with head and neck squamous cell carcinoma, high-resolution microendoscopic (HRME) imaging demonstrated a mean accuracy of 97% for specialists in identifying cancerous tissue, indicating its potential as a reliable tool for real-time margin assessment during surgery.

The inter-rater reliability among the seven trained specialists was high, with a Fleiss kappa statistic of 0.84, suggesting that HRME can be effectively used by different medical professionals to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discrimination of benign and neoplastic mucosa with a high-resolution microendoscope (HRME) in head and neck cancer. Vila, PM., Park, CW., Pierce, MC., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Operative margin control with high-resolution optical microendoscopy for head and neck squamous cell carcinoma. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Optical imaging with a high-resolution microendoscope to identify sinonasal pathology. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

High-Resolution Optical Imaging of Benign and Malignant Mucosa in the Upper Aerodigestive Tract: An Atlas for Image-Guided Surgery. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

In vivo diagnostic accuracy of high-resolution microendoscopy in differentiating neoplastic from non-neoplastic colorectal polyps: a prospective study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

High resolution microendoscopy for classification of colorectal polyps. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Optical imaging with a high-resolution microendoscope to identify cholesteatoma of the middle ear. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Discrimination of benign and neoplastic mucosa with a high-resolution microendoscope (HRME) in head and neck cancer. [2021]