Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Dysplasia; Oral Disorder; Lip and Oral Cavity Carcinoma; Premalignant Lesion

Treatments: Drug: Proflavine Hemisulfate; Procedure: High-Resolution Microendoscopy; Procedure: Fluorescence Imaging; Procedure: Biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02790853

P30CA016672 (U.S. NIH Grant/Contract)

NCI-2018-02554 (Registry Identifier)

2014-0831 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Diagnostic (multimodal imaging, biopsy)

Experimental group

Description:

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:

Procedure: Biopsy

Procedure: Fluorescence Imaging

Procedure: High-Resolution Microendoscopy

Drug: Proflavine Hemisulfate