Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

Early Phase 1

Active, not recruiting

• Conditions: Dysplasia; Lip and Oral Cavity Carcinoma; Oral Disorder; Premalignant Lesion
• Interventions: Procedure: Biopsy; Procedure: Fluorescence Imaging; Procedure: High-Resolution Microendoscopy; Drug: Proflavine Hemisulfate

• Registration Number: NCT02790853
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.

Study Timeline

• Study Start: 2016-05-25
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (multimodal imaging, biopsy)	Biopsy	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.
Diagnostic (multimodal imaging, biopsy)	Fluorescence Imaging	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.
Diagnostic (multimodal imaging, biopsy)	High-Resolution Microendoscopy	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.
Diagnostic (multimodal imaging, biopsy)	Proflavine Hemisulfate	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.

Primary Outcome Measures

Name	Time	Method
Detection of high grade dysplasia and carcinoma	Up to 2 years	Will 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).

Secondary Outcome Measures

Name	Time	Method
Cytologic results	Up to 2 years	Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.
Diagnostic assessment	Up to 2 years	Will determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.
Biomarker analysis	Up to 2 years	Will 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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States