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Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

NCT02790853 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ann Gillenwater · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-25
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02790853 on ClinicalTrials.gov