Proflavine: A Feasibility Study for In Vivo Imaging of Oral Neoplasia

This study is currently recruiting participants.
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01269190
First received: December 30, 2010
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

The goal of this clinical research study is to learn if new imaging devices can help doctors decide if a lesion in the mouth is pre-cancerous or cancerous. The new imaging devices use different colors of light in mouth imaging.


Condition Intervention
Head and Neck Cancer
Drug: Proflavine
Procedure: Imaging
Device: Widefield Multispectral Imaging Devices
Device: High-Resolution Microendoscope (HRME)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility Assessing Oral Mucosa In Vivo with Wide-field and High resolution Images using New Optical and Topically Contrast Agent [ Time Frame: 3 years for patient enrollment; patient participation 10 - 15 minute imaging and tissue biopsy procedure prior to surgery for removal of lesion ] [ Designated as safety issue: No ]
    Assessments: 1) Standard white light headlamp where clinical impression classified into "normal", "abnormal low risk", "abnormal high risk", or "cancer"; 2) Widefield multispectral imaging digital images before topical fluorescent dyes, and 3) digital images by a widefield multispectral imaging device &/or high-resolution optical system after topical dyes where images reviewed by investigators blinded to clinical impression and histopathology diagnosis, classify lesions as "suspicious" or "not suspicious"; and, 4) Histopathology based on biopsy samples used as gold standard.


Secondary Outcome Measures:
  • Number of subjects and lesions successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye [ Time Frame: 3 years for patient enrollment; patient participation 10 to 15 minute procedure including tissue biopsies done before surgery ] [ Designated as safety issue: No ]
    Several images of oral cavity mucosa taking approximately two minutes or less each, and removal for pathologic analysis of the measured sites


Estimated Enrollment: 155
Study Start Date: December 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mouth Exam
Oral mucosa in vivo assessment with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent.
Drug: Proflavine
Swabbing of inside mouth with cotton-tip applicator soaked in 0.01% proflavine hemisulfate, a fluorescent dye which glows green in the dark, placed on proposed evaluation sites for up to 30 seconds.
Other Name: proflavine hemisulfate
Procedure: Imaging
Imaging of inside mouth with multi-spectral digital microscope (MDM), the Identafi 3000, or portable screening system (PS2 or PS2.1) done first prior to swab with normal white light and second post swabbing of mouth with Proflavine at high magnification with High-Resolution Microendoscope (HRME).
Device: Widefield Multispectral Imaging Devices
Widefield multispectral imaging device used for imaging inside mouth: the Multi-spectral digital microscope (MDM) and/or the Identafi 3000 handheld system, and/or portable screening system (PS2 or PS2.1) both before and after Proflavine swabbing.
Device: High-Resolution Microendoscope (HRME)
High-resolution optical system used for imaging of inside mouth post proflavine application.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the Head & Neck area to remove or biopsy oral lesions will be eligible to participate in the study). Patients with previous treatment are eligible.
  2. Ability to understand and the willingness to sign a written Informed Consent Document (ICD).

Exclusion Criteria:

  1. Known allergy to proflavine or acriflavine.
  2. Age less than 18 years.
  3. Pregnant or nursing females.
  4. The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269190

Contacts
Contact: Ann M. Gillenwater, MD, BA 713-792-8841

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Ann M. Gillenwater, MD, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01269190     History of Changes
Other Study ID Numbers: 2008-0613
Study First Received: December 30, 2010
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
oral mucosa in vivo
Wide-Field In Vivo Imaging
High Resolution In Vivo Imaging
Oral Neoplasia
Topical Fluorescent Dyes
contrast dye
oral dysplasia
Proflavine
oral lesions
surgical resection
High Resolution Microendoscope
HRME
Identafi 3000
Multispectral Digital Microscope
MDM
Portable Screening System
PS2

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014