63 Participants Needed

Multimodal Imaging for Precancerous Oral Conditions

AG
Overseen ByAnn Gillenwater
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

Will I have to stop taking my current medications?

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

Is the multimodal imaging treatment generally safe for humans?

The studies mention the use of proflavine as a contrast agent in high-resolution microendoscopy for imaging various tissues, but they do not provide specific safety data for humans. There is no mention of adverse effects or safety concerns in the provided research articles.12345

How is the treatment for precancerous oral conditions using multimodal imaging unique?

This treatment is unique because it combines multiple imaging techniques, including fluorescence imaging and high-resolution microendoscopy, to noninvasively evaluate oral lesions. It allows for real-time visualization and analysis, helping to identify suspicious areas and avoid unnecessary biopsies, which is not typically possible with standard methods.678910

What data supports the effectiveness of the treatment Fluorescence Imaging, High-Resolution Microendoscopy, HRME, High-Resolution Microendoscopy, Proflavine Hemisulfate for precancerous oral conditions?

Research shows that high-resolution microendoscopy with proflavine can help visualize and distinguish between normal and abnormal tissue in real-time, which is useful for early detection of oral cancer and its precursors. This imaging technique has been effective in identifying changes in epithelial tissue, which is important for detecting early signs of cancer.13568

Who Is on the Research Team?

Ann M. Gillenwater | MD Anderson Cancer ...

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.
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: Diagnostic (multimodal imaging, biopsy)Experimental Treatment4 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.

Find a Clinic Near You

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 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.
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) 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.
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.
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

Physical and chemical stability of proflavine contrast agent solutions for early detection of oral cancer. [2015]
Optical imaging with a high-resolution microendoscope to identify cholesteatoma of the middle ear. [2021]
Optical imaging with a high-resolution microendoscope to identify sinonasal pathology. [2018]
Noninvasive imaging of oral neoplasia with a high-resolution fiber-optic microendoscope. [2021]
High-Resolution Optical Imaging of Benign and Malignant Mucosa in the Upper Aerodigestive Tract: An Atlas for Image-Guided Surgery. [2021]
In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience. [2018]
High resolution microendoscopy for classification of colorectal polyps. [2013]
Development of an integrated multimodal optical imaging system with real-time image analysis for the evaluation of oral premalignant lesions. [2020]
Design and validation of a diffuse reflectance and spectroscopic microendoscope with poly(dimethylsioxane)-based phantoms. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
In Vivo Multimodal Optical Imaging: Improved Detection of Oral Dysplasia in Low-Risk Oral Mucosal Lesions. [2019]
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