Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
3 other identifiers
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2016
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2016
CompletedFirst Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
April 15, 2026
April 1, 2026
10 years
May 26, 2016
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Diagnostic assessment
Up to 2 years
Biomarker analysis
Up to 2 years
Cytologic results
Up to 2 years
Study Arms (1)
Diagnostic (multimodal imaging, biopsy)
EXPERIMENTALParticipants 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.
Interventions
Undergo HRME imaging
Undergo brush biopsy and incisional biopsy
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Known allergy to proflavine or acriflavine.
- Pregnant females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Gillenwater
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 6, 2016
Study Start
May 25, 2016
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04