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Fluorescence Imaging

Multimodal Imaging for Precancerous Oral Conditions

Phase < 1

Waitlist Available

Led By Ann 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

Adult subjects with: history of resected oral cancer

Adult subjects with: oral potentially malignant disorder (OPMD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial uses new types of imaging devices to see if they can help doctors better determine if mouth lesions are pre-cancerous or cancerous.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects might include reactions related to the biopsy procedure and possible allergic responses to the proflavine hemisulfate used during imaging.

Eligibility Criteria

Inclusion Criteria

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

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I had surgery to remove oral cancer.

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I have a condition that might lead to mouth cancer.

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I have been diagnosed with dysplasia.

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I have a noticeable abnormal area or lesion in my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Carcinoma

Secondary study objectives

Biomarker analysis

Cytologic results

Diagnostic assessment

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Fluorescence Imaging

2014

Completed Phase 2

~100