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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Carcinoma
Secondary outcome measures
Biomarker analysis
Cytologic results
Diagnostic assessment

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
Proflavine
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,386 Total Patients Enrolled
5 Trials studying Oral Cancers
769 Patients Enrolled for Oral Cancers
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,583 Total Patients Enrolled
8 Trials studying Oral Cancers
1,904 Patients Enrolled for Oral Cancers
Ann GillenwaterPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
275 Total Patients Enrolled

Media Library

Fluorescence Imaging (Fluorescence Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT02790853 — Phase < 1
Oral Cancers Research Study Groups: Diagnostic (multimodal imaging, biopsy)
Oral Cancers Clinical Trial 2023: Fluorescence Imaging Highlights & Side Effects. Trial Name: NCT02790853 — Phase < 1
Fluorescence Imaging (Fluorescence Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02790853 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in the research project?

"Affirmative. According to the clinicaltrials.gov website, recruitment for this trial is ongoing; it was first published on May 25th 2016 and last modified on October 12th 2022. There are 600 slots available at 1 medical facility."

Answered by AI

Has High-Resolution Microendoscopy been a subject of any other research projects?

"Currently, there are 3 clinical trials in progress that research High-Resolution Microendoscopy and none of them have reached Phase 3. Primarily based in Houston, Texas these investigations into this medical technique span across three distinct locations."

Answered by AI

Does this experiment currently require the participation of new trial participants?

"Per clinicaltrials.gov, enrollment for this trial is open to the public. The study was initially published on May 25th 2016 and was recently updated on October 12th 2022."

Answered by AI
~14 spots leftby May 2026