Proflavine: A Feasibility Study for In Vivo Imaging of Oral Neoplasia
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01269190
First received: December 30, 2010
Last updated: August 10, 2016
Last verified: August 2016
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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: | 275 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | December 2018 (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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Ability to understand and the willingness to sign a written Informed Consent Document (ICD).
Exclusion Criteria:
- Known allergy to proflavine or acriflavine.
- Age less than 18 years.
- Pregnant or nursing females.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269190
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 | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Investigators
| Study Chair: | Ann M. Gillenwater, MD, BA | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01269190 History of Changes |
| Other Study ID Numbers: | 2008-0613 NCI-2015-01904 |
| Study First Received: | December 30, 2010 |
| Last Updated: | August 10, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
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:
|
Head and Neck Neoplasms Neoplasms Neoplasms by Site |
Proflavine Anti-Infective Agents, Local Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 30, 2016