338 Participants Needed

Fluorescent Imaging for Premalignant Oral Lesions

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

Trial Summary

What is the purpose of this trial?

This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

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 data supports the effectiveness of this treatment for premalignant oral lesions?

Research shows that using fluorescence imaging and spectroscopy can accurately diagnose precancerous and cancerous oral lesions in over 94% of cases. Additionally, multimodal imaging systems combining different types of optical imaging have been effective in identifying high-risk lesions and reducing unnecessary biopsies.12345

Is fluorescent imaging for premalignant oral lesions safe for humans?

The studies on fluorescent imaging techniques, such as multimodal optical imaging and laser confocal endomicroscopy, suggest that these methods are noninvasive and have been used safely in humans to detect oral lesions. They involve using light to create images of the mouth's tissues, which does not appear to pose significant safety risks.12456

How does fluorescent imaging differ from other treatments for premalignant oral lesions?

Fluorescent imaging for premalignant oral lesions is unique because it uses light to detect changes in tissue, allowing for real-time, noninvasive evaluation. This method can identify suspicious areas with high sensitivity and avoid unnecessary biopsies, unlike traditional methods that rely solely on visual inspection and biopsy.13457

Research Team

Ann M. Gillenwater | MD Anderson Cancer ...

Ann M. Gillenwater

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

I am under 18 years old.
I am unable or unwilling to give informed consent.

Timeline

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

Treatment Details

Interventions

  • Cytology Specimen Collection Procedure
  • Diagnostic Microscopy
  • Fluorescence Imaging
  • Fluorescence Spectroscopy
  • Reflectance Imaging
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Diagnostic (fluorescent/reflectance imaging, spectroscopy)Experimental Treatment5 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.

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+

Findings from Research

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

References

1.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[The diagnosis of precancerous diseases and cancer of the lip and oral mucosa by using contact fluorescence biomicroscopy]. [2012]
Ex vivo confocal imaging with contrast agents for the detection of oral potentially malignant lesions. [2021]
Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy. [2016]
Prospective evaluation of oral premalignant lesions using a multimodal imaging system: a pilot study. [2021]
Development of an integrated multimodal optical imaging system with real-time image analysis for the evaluation of oral premalignant lesions. [2020]
Laser confocal endomicroscopy as a novel technique for fluorescence diagnostic imaging of the oral cavity. [2019]
Time-resolved fluorescence spectroscopy as a diagnostic technique of oral carcinoma: Validation in the hamster buccal pouch model. [2021]