Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders

  • End date
    May 31, 2026
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 20 October 2022
proflavine hemisulfate
high-resolution microendoscopy
multimodal imaging
oral cancer


This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.



I. To compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).


I. To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.

II. To compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.

III. To compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.


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.

After completion of study treatment, patients are followed up at 30 days.

Condition Dysplasia, Lip and Oral Cavity Carcinoma, Oral Disorder, Premalignant Lesion
Treatment biopsy, fluorescence imaging, Tissue Biopsy, White Light (WL) Clinical Examination, PS2.1/PS3 Imaging, Proflavine Hemisulfate, Proflavine Hemisulfate, High-Resolution Optical System (HRME), Brush Biopsy, High-Resolution Microendoscopy
Clinical Study IdentifierNCT02790853
SponsorM.D. Anderson Cancer Center
Last Modified on20 October 2022


Yes No Not Sure

Inclusion Criteria

Subjects who are willing to participate
Adult subjects with: a. clinically evident oral premalignant lesion (OPL) or suspicious oral mucosal lesion. or b. pathologic diagnosis of dysplasia or c. history of resected oral cancer or d. oral potentially malignant disorder (OPMD) or e. history of tobacco and/or alcohol exposure
Ability to understand and willingness to sign a written informed consent document (ICD)

Exclusion Criteria

Known allergy to proflavine or acriflavine
Pregnant females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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