Precision Optical Guidance for Mouth Sores

Recruiting in Palo Alto (17 mi)

Overseen by Ann M. Gillenwater

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergy to proflavine, acriflavine, others

No Placebo Group

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.

Trial 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) (Imaging Device)
• Optical Mapping Scope (Imaging Device)
• Proflavine hemisulfate (Diagnostic Agent)

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 China for the following indications:

Approved in China as HRME for:

• Esophageal squamous cell neoplasia detection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Patients Recruited

853,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]