NCT02790853

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo brush biopsy and incisional biopsy
PROCEDURE	Fluorescence Imaging	Undergo PS2.1/PS3 imaging
PROCEDURE	High-Resolution Microendoscopy	Undergo HRME imaging
DRUG	Proflavine Hemisulfate	Applied on mucosa

Timeline

• Start date: 2016-05-25
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2016-06-06
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study