Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

Dysplasia Clinical Trial

Official title:

Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02790853
• Other study ID #: 2014-0831
• Secondary ID: NCI-2018-0255420
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: May 25, 2016
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biopsy
Undergo brush biopsy and incisional biopsy
• Fluorescence Imaging
Undergo PS2.1/PS3 imaging
• High-Resolution Microendoscopy
Undergo HRME imaging

Drug:
• Proflavine Hemisulfate
Applied on mucosa

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of high grade dysplasia and carcinoma	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).	Up to 2 years
Secondary	Diagnostic assessment	Will determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.	Up to 2 years
Secondary	Biomarker analysis	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.	Up to 2 years
Secondary	Cytologic results	Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.	Up to 2 years

External Links

•   MD Anderson Cancer Center Website