Precision Optical Guidance for Mouth Sores

Overseen By Ann Gillenwater, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergy to proflavine, acriflavine, others

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

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High Resolution Microendoscope (HRME) for mouth sores?

The High Resolution Microendoscope (HRME) has been shown to effectively differentiate between benign and cancerous tissues in the head, neck, and colorectal areas, suggesting it could help identify and treat mouth sores by providing detailed images of the affected areas. ^{1 2 3 4 5}

Is the Precision Optical Guidance for Mouth Sores safe for humans?

The High Resolution Microendoscope (HRME), which is similar to the Precision Optical Guidance, has been used safely in studies for imaging the digestive tract and other areas. These studies did not report any significant safety concerns, suggesting it is generally safe for human use. ^{1 3 4 5 6}

How is the treatment for mouth sores using High Resolution Microendoscope (HRME) unique?

The High Resolution Microendoscope (HRME) is unique because it provides real-time, non-invasive imaging of the mucosal surface, allowing for immediate differentiation between healthy and abnormal tissue. This 'optical biopsy' technology offers a novel approach to diagnosing and guiding treatment without the need for traditional, more invasive biopsy methods. ^{2 3 4 5 7}

Research Team

Ann M. Gillenwater

Principal Investigator

MD Anderson Caner Center

Eligibility Criteria

This trial is for adults with visible mouth sores, like leukoplakia or erythroplakia, conditions that could turn into cancer, a history of oral cancer treatments, or diagnosed dysplasia. Participants must understand and sign consent forms. It's not for those allergic to proflavine, under 18, pregnant/nursing women, those unable to consent legally or prisoners.

Inclusion Criteria

Ability to understand and willingness to sign a written Informed Consent Document (ICD)

I have had cancer treatments like surgery, radiation, or chemotherapy before.

I have oral lesions or a history of oral cancer.

Exclusion Criteria

Known allergy to proflavine or acriflavine

Prisoners and other vulnerable populations

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy Guidance

Participants undergo imaging with the Active Biopsy Guidance System to evaluate its technical performance and assist in biopsy decision-making

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after the imaging and biopsy procedures

4 weeks

Treatment Details

Interventions

• High Resolution Microendoscope (HRME)
• Optical Mapping Scope
• Proflavine hemisulfate

Trial Overview The study tests the Active Biopsy Guidance System using High Resolution Microendoscope (HRME), Optical Mapping Scope and Proflavine hemisulfate to see if it helps doctors better decide when and where to biopsy mouth lesions.

Participant Groups

Group I: The Active Biopsy Guidance System Experimental Treatment 3 Interventions

This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):

High Resolution Microendoscope (HRME) is already approved in United States, China for the following indications:

Approved in United States as HRME for:

• Oral biopsy guidance
• Esophageal squamous cell neoplasia detection
• Cervical neoplasia detection

Approved in China as HRME for:

• Esophageal squamous cell neoplasia detection

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Findings from Research

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) is a novel imaging technique that allows for real-time imaging of tissues, showing promise for immediate diagnosis in clinical settings.

The successful imaging of the gastrointestinal tract in animal studies demonstrates HRME's potential for virtual pathology, paving the way for future clinical research and applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Construction and Preliminary Application of High Resolution Microendoscopy Imaging System]. Qu, Y., Tan, T., Zhang, Y., et al.[2018]

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) 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]

The high-resolution microendoscope (HRME) allows gastroenterologists, even those without prior experience, to accurately identify Barrett's-associated neoplasia with a high sensitivity of 90% and specificity of 82%, based on a study involving 20 gastroenterologists reviewing 40 images from 28 patients.

There was no significant difference in diagnostic accuracy between novice and expert microendoscopists, indicating that HRME can be effectively utilized in community settings for surveillance of Barrett's esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and interrater reliability for the diagnosis of Barrett's neoplasia among users of a novel, portable high-resolution microendoscope. Vila, PM., Kingsley, MJ., Polydorides, AD., 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. Australia pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. China pubmed.ncbi.nlm.nih.gov

[Construction and Preliminary Application of High Resolution Microendoscopy Imaging System]. [2018]

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

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

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

Accuracy and interrater reliability for the diagnosis of Barrett's neoplasia among users of a novel, portable high-resolution microendoscope. [2021]

7. 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]