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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging device called the Active Biopsy Guidance System, designed to help doctors identify the best biopsy sites for mouth sores. The device consists of a high-resolution camera and an optical mapping scope, which aim to improve decision-making for treating potentially cancerous lesions. Suitable participants may have mouth lesions such as leukoplakia (white patches) or erythroplakia (red patches), or a history of oral cancer or certain other mouth conditions. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future diagnostic techniques.

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 prior data suggests that the Active Biopsy Guidance System is safe for use in guiding biopsies of mouth lesions?

Research has shown that the High Resolution Microendoscope (HRME) and the Optical Mapping Scope capture detailed images of mouth tissues. These noninvasive tools do not require cutting into the body. Studies have found that the HRME provides real-time images at a very small scale, almost at the cellular level, allowing doctors to see detailed pictures without surgery.

Regarding safety, the HRME and Optical Mapping Scope are generally well-tolerated. Their noninvasive nature means they avoid the risks associated with surgery. So far, no significant negative side effects have been reported with these imaging tools, suggesting they are safe for use in people. However, like any medical procedure, risks may exist, so discussing them with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Precision Optical Guidance for Mouth Sores because it offers a new way to improve diagnosis accuracy. Unlike traditional methods, which often rely on visual inspection and standard biopsies, this approach uses a high-resolution microendoscope (HRME) and an optical mapping scope to precisely guide biopsies. This technology allows for real-time imaging at the cellular level, potentially leading to more accurate and earlier detection of problematic cells. By enhancing precision, this method could minimize unnecessary tissue removal and reduce patient discomfort associated with traditional biopsy procedures.

What evidence suggests that the Active Biopsy Guidance System is effective for guiding biopsies of mouth lesions?

Research has shown that the High Resolution Microendoscope (HRME) and Optical Mapping Scope, part of the Active Biopsy Guidance System studied in this trial, help doctors see changes in mouth cells in great detail. The HRME provides real-time images of tiny structures inside cells, making it easier to identify problems without immediately cutting into tissue. Studies indicate that these tools offer clear guidance on where to take a biopsy, which involves taking a small tissue sample to check for disease. This method can make diagnosing mouth issues faster and more accurate. Overall, these imaging tools hold promise for improving how doctors decide when and where to perform biopsies, potentially reducing unnecessary procedures. ^{2 6 7 8 9}

Who Is on the Research Team?

Ann M. Gillenwater

Principal Investigator

MD Anderson Caner Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4250374/

Applications and Advancements in the use of High ... The high-resolution microendoscope (HRME) is a novel imaging modality that allows real-time epithelial imaging at subcellular resolution.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1046202325001124

Enabling high-resolution diagnostic oral confocal laser ... This study introduces a refined diagnostic methodology for non-invasive cellular-level imaging for diagnosis of micro-lesions by utilizing high-resolution ...

3. kortum.rice.edu kortum.rice.edu/research/funded-project-effectiveness-high-resolution-microendoscopy

The Effectiveness of High Resolution Microendoscopy (HRME ... The goal of this project is to develop and optimize a) mHRME with 3D image mapping and b) image-analysis software for anal High Grade Squamous Intraepithelial ...

4. eurekalert.org eurekalert.org/news-releases/977123

Accurate integrated imaging and projection system for oral ... Researchers propose a versatile imaging platform that provides clinically actionable direct visible guidance for oral cancer diagnosis.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05554133/precision-optical-guidance-for-oral-biopsy

Precision Optical Guidance for Oral Biopsy 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3078517/

Noninvasive imaging of oral neoplasia with a high-resolution ... The purpose of this study was to evaluate the ability of high-resolution microendoscopy to image and quantify changes in cellular and architectural features ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00488332

An Exploratory Study on Optical Assessment of Oral ... Optical coherence tomography (OCT) works similarly to ultrasound but uses infrared light waves rather than sound waves to create high-resolution ...

8. researchgate.net researchgate.net/publication/50410601_Noninvasive_imaging_of_oral_neoplasia_with_a_high-resolution_fiber-optic_microendoscope

(PDF) Noninvasive imaging of oral neoplasia with a high- ... The purpose of this study was to evaluate the ability of high-resolution microendoscopy to image and quantify changes in cellular and ...

9. clinicaltrial.be clinicaltrial.be/en/details/14556?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Precision Optical Guidance for Oral Biopsy - Clinical Tri... The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at ...