Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02790853

Enrollment

Registered

2016-06-06

Start date

2016-05-25

Completion date

2026-05-31

Last updated

2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia, Lip and Oral Cavity Carcinoma, Oral Disorder, Premalignant Lesion

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.

Interventions

PROCEDUREBiopsy

Undergo brush biopsy and incisional biopsy

PROCEDUREFluorescence Imaging

Undergo PS2.1/PS3 imaging

PROCEDUREHigh-Resolution Microendoscopy

Undergo HRME imaging

DRUGProflavine Hemisulfate

Applied on mucosa

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Cytologic results	Up to 2 years	Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026