Fluorescent Imaging for Premalignant Oral Lesions

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 18, Unable to consent

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

Compensation: Varies

Number of Visits: Unknown

338 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to detect early signs of oral cancer using special imaging techniques. It employs light in different colors to capture detailed images inside the mouth, aiding in the identification of abnormal cells that might develop into cancer. Participants will undergo examinations with various imaging tools, including fluorescence imaging, and may have small mouth tissue samples analyzed under a microscope. This trial suits individuals with spots or patches in their mouths that could become cancerous, those with a history of head and neck cancer, or heavy tobacco users. As an unphased trial, participants contribute to innovative research that may lead to earlier detection of oral cancer.

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 diagnostic procedures are safe for detecting oral lesions?

Research has shown that special light techniques, such as fluorescence and reflectance imaging, are generally safe and well-tolerated by patients. These methods help doctors detect early signs of oral cancer without major side effects. Fluorescence imaging uses special lights to capture images inside the mouth, aiding in spotting tissue changes.

Patients have also undergone fluorescence spectroscopy, which uses light to gather information about tissue. This method has been tested on both healthy volunteers and those with oral changes, proving it is usually safe. These procedures are non-invasive, meaning they don't involve cutting into the body, making them easier on patients compared to other tests.

Overall, these imaging techniques aim to catch early signs of oral cancer and are considered safe based on past research. They use light and cameras, posing less risk than more invasive medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this new approach to identifying premalignant oral lesions because it uses advanced imaging techniques like fluorescence and reflectance imaging, which can highlight abnormal tissue in ways that standard white light cannot. This allows for clearer differentiation between healthy and potentially cancerous tissue, offering a more precise and less invasive alternative to traditional biopsy methods. Additionally, the use of fluorescence spectroscopy provides molecular-level insights, which could lead to earlier and more accurate detection of oral cancers, potentially improving patient outcomes.

What evidence suggests that these diagnostic procedures are effective for detecting premalignant oral lesions?

Research has shown that special imaging techniques can detect early signs of mouth cancer. In this trial, participants will undergo diagnostic procedures using methods such as autofluorescence, which uses light to make tissues glow, aiding doctors in spotting early changes. Another method, fluorescence spectroscopy, also detects changes in mouth tissues that might lead to cancer. Combining these techniques in this trial helps doctors find and monitor early cancer signs more effectively. Early detection is crucial because it can simplify treatment and improve outcomes. ^{1 6 7 8 9}

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 at high risk of developing oral cancer, including those with conditions like lichen planus, Fanconi anemia, heavy tobacco use, or premalignant lesions in the mouth. It's also open to patients with a history of head and neck cancer but currently show no signs of disease.

Inclusion Criteria

I had head or neck cancer or precancerous oral conditions but currently show no signs of disease.

I have a precancerous lesion in my mouth.

I have a history of oral cancer or pre-cancerous oral conditions.

Exclusion Criteria

I am under 18 years old.

I am unable or unwilling to give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically.

Ongoing

Multiple visits as needed

Follow-up

Participants may undergo repeated imaging procedures and biopsy during subsequent follow-up visits to monitor for carcinogenic progression.

Up to 10 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Cytology Specimen Collection Procedure
• Diagnostic Microscopy
• Fluorescence Imaging
• Fluorescence Spectroscopy
• Reflectance Imaging

Trial Overview The study tests imaging techniques that detect light emitted from tissues (fluorescence) to monitor for early signs of oral cancer. This includes taking pictures inside the mouth using special lights and cameras, as well as examining tissue samples under a microscope.

How Is the Trial Designed?

Group I: Diagnostic (fluorescent/reflectance imaging, spectroscopy) Experimental Treatment 5 Interventions

Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.

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

Fluorescence imaging using 5-aminolevulinic acid significantly improves the detection of premalignant and malignant lesions in the oral cavity, with a sensitivity of 83-90% and specificity of 79-89% based on a study of 71 patients.

This technique offers advantages over traditional methods, providing real-time diagnosis and in situ monitoring, making it a more patient-friendly option compared to surgical biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy. Sharwani, A., Jerjes, W., Salih, V., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2929485/

Advances in fluorescence imaging techniques to detect oral ... Autofluorescence imaging has emerged as a promising adjunctive technique to improve early identification of oral premalignant lesions.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118307787

Fluorescence spectroscopic study on malignant and ... To evaluate the changes of oral mucosa in malignancy and pre-malignant oral conditions using fluorescence spectroscopy during various phases of treatment.

3. nature.com nature.com/articles/ijos201439

The clinical effectiveness of reflectance optical ... The overall 5-year survival rates for oral cancer have remained low at approximately 50% for the past decades and are considered among the worst ...

4. journals.lww.com journals.lww.com/joro/_layouts/15/oaks.journals/downloadpdf.aspx?an=01519309-201103010-00012

Volum3 Issue 1.pmd In dentistry, the autofluorescence techniques have been tried to identify various premalignant and malignant lesions of oral mucosa3. These ...

5. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2480448

Fluorescence Visualization–Guided Surgery for Early- ... This cohort study compares outcomes for patients with early-stage oral cancer who underwent fluorescence visualization–guided vs conventional surgery.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772906024000189

Use of fluorescence imaging and spectrometry in detection ... The use of fluorescence imaging and spectrometry for early detection of oral cancer has the potential for improving the screening at a mass level especially in ...

7. nature.com nature.com/articles/s41598-025-94676-w

Integration of the fluorescence based portable device with ... Here, we have summarized the key findings of the research carried out by the research groups for in-vivo detection of oral cancer using ...

8. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/221188

Noninvasive Diagnosis of Oral Neoplasia Based on ... Design A fluorescence spectroscopy system recorded spectra from oral cavity sites in 8 healthy volunteers and in 15 patients with premalignant or malignant oral ...

9. ahns.info ahns.info/wp-content/uploads/2017/05/Early-Detection-of-Pre-Malignant-Oral-Cancer-FINAL.pdf

Early-Detection-of-Pre-Malignant-Oral-Cancer- ... Diagnostic accuracy of diffuse reflectance imaging for early detection of pre-malignant and malignant changes in the oral cavity: a feasibility ...