Multimodal Imaging for Precancerous Oral Conditions

Overseen By Ann Gillenwater

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergy to proflavine, acriflavine, pregnant

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

Compensation: Varies

Number of Visits: 1

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new imaging methods to detect pre-cancerous and cancerous spots in the mouth. It employs special imaging techniques, such as Fluorescence Imaging and High-Resolution Microendoscopy (HRME), along with a dye called Proflavine Hemisulfate, to help doctors determine if a mouth lesion (a sore or lump) could be cancerous. Individuals with potentially pre-cancerous mouth sores, a history of oral cancer, or significant tobacco or alcohol use might be suitable candidates for this study. Participants will undergo imaging and may have small samples taken from their mouth every few months. As an Early Phase 1 trial, this study aims to understand how these new imaging techniques function in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these imaging techniques are safe for patients with oral potentially malignant disorders?

Research shows that the treatments in this trial are generally easy for patients to handle. Studies have found that using special imaging techniques, such as fluorescence imaging and high-resolution microendoscopy, along with the dye proflavine hemisulfate, results in manageable side effects. These methods enhance doctors' ability to see changes in mouth tissues clearly.

Proflavine hemisulfate makes cells easier to see during imaging. Previous research indicates that using this dye with imaging techniques is safe for individuals with oral conditions. Serious side effects are rare, as no major adverse events have been reported. Overall, patients have undergone these treatments without significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these imaging techniques for detecting precancerous oral conditions because they offer a non-invasive and precise way to identify abnormal areas in the mouth. Unlike standard methods that may rely heavily on visual inspection and traditional biopsies, fluorescence imaging and high-resolution microendoscopy allow for detailed visualization of tissue changes. The use of proflavine hemisulfate as a contrast agent enhances the imaging quality, potentially enabling earlier and more accurate detection of precancerous changes, which could lead to better patient outcomes.

What evidence suggests that multimodal imaging is effective for detecting precancerous oral conditions?

Research has shown that combining different imaging techniques, such as special light imaging and detailed microscopic imaging, can detect early signs of oral cancer. In this trial, participants will undergo multimodal imaging, which includes fluorescence imaging and high-resolution microendoscopy with proflavine hemisulfate applied to the mucosa. Studies have found that this detailed imaging can identify changes in cells and tissues with 86% accuracy for true positives and 87% accuracy for true negatives. The dye proflavine hemisulfate enhances image clarity, aiding doctors in earlier and more accurate detection of issues. This method aims to provide a noninvasive way to monitor oral health and detect potential cancer early. ^{1 2 3 4 6}

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 that may become cancerous, a history of resected oral cancer, or exposure to tobacco/alcohol. Participants must be willing and able to consent. Pregnant individuals or those allergic to proflavine/acriflavine cannot join.

Inclusion Criteria

I had surgery to remove oral cancer.

Ability to understand and willingness to sign a written informed consent document (ICD)

I have a condition that might lead to mouth cancer.

Exclusion Criteria

Known allergy to proflavine or acriflavine

Pregnant females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa, along with brush and incisional biopsies, repeated every 3-4 months

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fluorescence Imaging
• High-Resolution Microendoscopy
• Proflavine Hemisulfate

Trial Overview The study tests new imaging methods (fluorescence imaging, high-resolution microendoscopy) using proflavine hemisulfate on patients with potentially malignant mouth disorders to see if these can identify pre-cancerous or cancerous lesions effectively.

How Is the Trial Designed?

Group I: Diagnostic (multimodal imaging, biopsy) Experimental Treatment 4 Interventions

Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.

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) 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]

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) 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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9944690/

Automated In Vivo High-Resolution Imaging to Detect ... This work aims to demonstrate the potential of high-resolution microendoscopy (HRME) coupled with a novel machine learning algorithm for the automated, in vivo ...

2. withpower.com withpower.com/trial/multimodal-imaging-for-precancerous-oral-conditions-1328b

Multimodal Imaging for Precancerous Oral Conditions The use of proflavine hemisulfate as a contrast agent enhances the imaging quality, potentially enabling earlier and more accurate detection of precancerous ...

3. 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 ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/01455613241245204

Past, Present, and Future Diagnostic Methods for the Early ... Results: Several noninvasive techniques have shown varying degrees of effectiveness in detecting oral cancer. Autofluorescence imaging exhibited ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT01269190

Wide-Field and High Resolution In Vivo Imaging ... This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth ( ...