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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve how doctors identify potential pre-cancerous or cancerous lesions in the mouth using advanced imaging technology. Devices shine different colors inside the mouth and take detailed pictures to help assess the risk of oral lesions. The trial employs High-Resolution Microendoscopy and Multispectral Imaging, advanced imaging techniques, along with Proflavine, a dye that highlights abnormal cells. Participants with oral lesions scheduled for surgery or biopsy are sought for this study. This research could enhance the diagnosis of oral cancer, making it easier to detect risky lesions early. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could revolutionize oral cancer diagnosis.

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 prior data suggests that these imaging devices are safe for diagnosing oral lesions?

Research shows that the treatments under study, such as high-resolution microendoscopy and multispectral imaging, hold promise for safely aiding doctors in early oral cancer detection. Studies highlight that high-resolution microendoscopy, which uses a special camera to closely examine mouth tissues, is generally safe. It can identify cellular changes without causing harm. This method has been tested with a substance called proflavine, and no major safety issues have been reported.

Multispectral imaging, another technique under study, uses different light colors to detect signs of cancer in the mouth. Previous research has shown this tool can help find cancer early, and it has been used without significant safety concerns.

Together, these techniques aim to improve cancer detection and enhance safety, without posing unnecessary risks to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using high-resolution microendoscopy and multispectral imaging for oral cancer because these techniques offer a non-invasive way to evaluate the oral cavity with exceptional detail. Unlike standard methods like biopsies, which can be invasive and uncomfortable, these imaging techniques allow for real-time visualization of cells without needing to remove tissue. Additionally, the use of proflavine as a fluorescent dye enhances the visibility of abnormal cells, potentially improving early detection and diagnosis. This could lead to more accurate treatment planning and better outcomes for patients.

What evidence suggests that these imaging techniques are effective for visualizing oral lesions?

This trial will evaluate the use of multispectral imaging and high-resolution microendoscopy (HRME) for early detection of oral cancer. Research has shown that multispectral imaging is a promising tool, using different colors of light to identify changes in mouth tissue that might indicate cancer. This method effectively identifies cancerous changes early. Meanwhile, HRME demonstrated a high accuracy rate of 95.1% in distinguishing between non-cancerous and cancerous tissue by capturing detailed images of cells. Participants in this trial will undergo both techniques, which could aid in early detection of oral cancer, crucial for better outcomes. ^{4 5 6 7 8}

Who Is on the Research Team?

Ann M. Gillenwater

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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 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]

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]

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) 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 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) 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04563754

The Effectiveness of High Resolution Microendoscopy for ... The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3421068/

Discrimination of Benign and Neoplastic Mucosa with a ... Our aim was to determine the accuracy and inter-rater reliability of head and neck cancer specialists using high-resolution microendoscopic (HRME) images.

3. gastrojournal.org gastrojournal.org/article/S0016-5085%2824%2905643-9/fulltext

A High-Resolution Microendoscope Improves Esophageal ... HRME increased efficiency in screening: diagnostic yield (neoplastic/total biopsies) improved from 20.0% (95% confidence interval [CI], 12.7– ...

4. withpower.com withpower.com/trial/early-phase-1-mouth-neoplasms-11-2010-609c0

Multispectral + High-Resolution Microendoscopy for Oral ... High-resolution microendoscopy (HRME) demonstrated a mean accuracy of 95.1% in distinguishing between benign and malignant mucosa in patients with squamous cell ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0044924

High-Resolution Microendoscopy for the Detection of Cervical ... Quantitative high resolution imaging achieved a sensitivity and specificity of 86% and 87%, respectively, in differentiating neoplastic (≥CIN 2) tissue from non ...

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/NCT01269190

Wide-Field and High Resolution In Vivo Imaging ... To identify qualitative and quantitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions.

8. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/5/6/801/50010/Accuracy-of-In-Vivo-Multimodal-Optical-Imaging-for

Accuracy of In Vivo Multimodal Optical Imaging for Detection ... In this study, wide-field AFI and high-resolution microendoscopy were carried out in patients undergoing surgery for oral cancer or dysplasia. At each ...