What side effects are associated with this type of intervention?

Fluorescence and Reflectance Imaging, as well as Fluorescence Spectroscopy, are non-invasive diagnostic techniques used to detect abnormal cells in oral tissues. These methods generally have minimal side effects, primarily limited to mild discomfort or irritation at the site of examination. Unlike more invasive procedures, they do not typically cause significant pain or require recovery time. However, patients may experience temporary sensitivity to light following the procedure. Overall, these imaging techniques are considered safe and well-tolerated.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for oral tumors that utilize fluorescence and reflectance imaging or fluorescence spectroscopy for detection. However, these investigational methods are being studied to enhance early detection and monitoring of oral cancer. Broadly, FDA-approved treatments for oral tumors include surgical resection, radiation therapy, and chemotherapy, often combined with targeted therapies such as cetuximab, an EGFR inhibitor, for advanced cases.

What other types of research exist?

Promising novel alternatives for detecting oral tumors include: 1) Optical Coherence Tomography (OCT), which provides high-resolution cross-sectional images of tissue structures. 2) Raman Spectroscopy, which analyzes molecular composition and can detect biochemical changes in tissues. 3) Liquid Biopsy, which involves analyzing circulating tumor DNA (ctDNA) or other biomarkers in blood samples for early detection of cancer. 4) Artificial Intelligence (AI)-enhanced imaging, which uses machine learning algorithms to improve diagnostic accuracy and identify patterns in imaging data.

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Fluorescent Imaging for Premalignant Oral Lesions

N/A

Waitlist Available

Led By Ann M Gillenwater

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease

Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)

Must not have

Subjects under the age of 18

Subjects that are unable or unwilling to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Summary

This trial is examining if using fluorescent imaging, spectroscopy, and tissue samples can help detect oral cancer earlier.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than drug treatments, side effects are minimal but may include discomfort from the imaging equipment or during sample collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have a precancerous lesion in my mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am unable or unwilling to give informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lesions diagnosed via non-invasive brush cytology

Lesions diagnosed via point spectroscopy system

Lesions diagnosed via wide-field fluorescence imaging

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diagnostic Microscopy

2017

Completed Early Phase 1

~100

Fluorescence Spectroscopy

1999

N/A

~390

Fluorescence Imaging

2014

Completed Phase 2

~100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for oral tumors include surgery, radiation therapy, and chemotherapy. Surgery involves the physical removal of the tumor, which is often the first line of treatment. Radiation therapy uses high-energy rays to target and kill cancer cells, while chemotherapy employs drugs to destroy cancer cells throughout the body. Fluorescence and reflectance imaging, along with fluorescence spectroscopy, are advanced diagnostic techniques that help detect abnormal cells by using light-induced fluorescence. These methods are crucial for early detection, allowing for timely and more effective treatment, which can significantly improve outcomes for oral tumor patients.

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,363 Total Patients Enrolled

2 Trials studying Oral Tumors

70 Patients Enrolled for Oral Tumors

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,662 Total Patients Enrolled

Ann M GillenwaterPrincipal InvestigatorM.D. Anderson Cancer Center

~11 spots leftby Apr 2025

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