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Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders

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ClinicalTrials.gov Identifier: NCT02790853
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
William Marsh Rice University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

This is an investigational study. The HRME and PS2.1/PS3 imaging devices are not FDA approved or commercially available. Their use in this study is considered investigational. Proflavine hemisulfate is FDA approved and commercially available for treating umbilical cord stumps of newborn babies. Proflavine hemisulfate is not FDA approved or commercially available to use as a dye in the mouth. Its use in this study is considered investigational.

The study doctor can explain to you how the imaging devices are designed to work.

Up to 600 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Oral Potentially Malignant Disorders Procedure: White Light (WL) Clinical Examination Device: PS2.1/PS3 Imaging Other: Proflavine Hemisulfate Device: High-Resolution Optical System (HRME) Procedure: Brush Biopsy Procedure: Tissue Biopsy Not Applicable

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Detailed Description:

Study Visits:

While you are on study, you will have about 4 study visits during an already scheduled, routine clinic visit. Each visit will last about 20-25 minutes total. During each visit, you will have your mouth examined and imaged and you will have brush and tissue biopsies to check for any cancerous or pre-cancerous lesions. These tests and procedures are described below.

Mouth Exam and Imaging:

Two (2) different kinds of imaging devices are being used in this study to compare to standard white light exams. One type, PS2.1/PS3, is designed to let researchers look at a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures.

The other imaging device is called the high-resolution microendoscope (HRME) and is designed to let researchers look at and take pictures of a very small area of the lining of the mouth but with a high magnification (like a microscope).

If you are found to be eligible to take part in this study and you agree, you will have a mouth exam and your mouth will be scanned with both types of imaging devices and pictures of any mouth lesions will be taken. Normal (non-lesion) tissue in your mouth may also be imaged.

First, you will have a standard white light mouth exam. During the exam, the study doctor will look for any lesions in your mouth and pictures of any found lesions will be taken.

After the white light mouth exam, the study doctor will then take pictures of the inside of your mouth using the PS2.1/PS3 imaging device.

You will also have pictures of your mouth taken with the HRME. To do this, a coloring substance called proflavine hemisulfate (a type of fluorescent dye which glows green in the dark) will be "painted" on areas of your mouth with a cotton tip to help improve the pictures. Then, a small probe (about the size of a pencil tip) of the HRME will be placed against the lesions and the normal areas inside your mouth and light from the end of the HRME probe will be used to take a picture. After the pictures have been taken, you will rinse your mouth with water.

It should take about 5-10 minutes total to have your mouth examined and imaged under white light, using the PS2.1/PS3 device, and the HRME.

Brush Biopsy and Tissue Biopsies:

After all imaging has been completed, you will have a brush biopsy of your mouth to check if the cells are cancerous and to learn if there have been any changes in the cells between visits. To perform a brush biopsy, a member of the study staff will gently rotate a brush along the surface of the mouth. This test is similar to a "Pap Smear" test used to screen women for cervical cancer.

You will also have tissue biopsies to check if the tissue is cancerous or pre-cancerous. To collect a tissue biopsy, your mouth will be numbed with local anesthesia and a small cutting tool will be used to remove tissue from the lesions.

The results of the biopsies will be compared to the images taken with the PS2.1/PS3 and HRME devices to learn if the imaging devices accurately predicted if a lesion was cancerous or pre-cancerous.

It should not take more than 15 minutes to complete all biopsies. The mouth exam, imaging, and biopsies will all take place on the same day during a routine clinic visit.

Other Information:

You will not be told of any of the imaging results of this study because they are for research purposes only. However, the results of the biopsies will be available to you and your doctor.

All study data will be coded with a number, instead of your personal identifying information (such as your name or medical record number), to help ensure your privacy.

Length of Study:

Your participation on this study will be over after you have completed follow-up.

Follow-Up:

About 30 days after your last clinic visit, your medical records will be checked and/or a member of the study staff may call you to learn if you had any side effects from the imaging devices. If you are called, this call should last about 5 minutes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mouth Exam + Diagnostic Optical Imaging

Participants undergo a standard white light (WL) mouth exam. After the white light mouth exam, pictures of the inside of mouth taken using a wide-field auto-fluorescence imaging device (PS2.1/PS3) imaging device.

After the white light mouth exam, proflavine hemisulfate placed on the mucosa around the involved area. Then oral mucosa re-imaged with the high-resolution optical system (HRME).

Brush and tissue biopsies then performed.

Procedure: White Light (WL) Clinical Examination
Participant's oral cavity inspected using a standard white light headlamp.

Device: PS2.1/PS3 Imaging
Participant's oral cavity examined with wide-field auto-fluorescence imaging device PS2.1/PS3. Clinical images recorded from a normal area and from any other suspicious or unusual areas.

Other: Proflavine Hemisulfate
A cotton-tip applicator soaked in 0.01% proflavine hemisulfate placed on the oral mucosa around the involved area before re-imaging with high-resolution optical system (HRME).

Device: High-Resolution Optical System (HRME)
After proflavine hemisulfate applied, oral mucosa re-imaged with high-resolution optical system (HRME). Clinical images recorded.

Procedure: Brush Biopsy
Soft oral cell sampler biopsy brush pressed against the lesion and rotated 5-10 times or more depending on the thickness of the lesion.

Procedure: Tissue Biopsy
Oral areas requiring pathologic assessment biopsied. After local anesthesia, a 4 or 5 mm punch biopsy instrument used to remove the oral tissue.




Primary Outcome Measures :
  1. Multimodal Imaging for Detection of High Grade Dysplasia and Carcinoma [ Time Frame: 2 years ]
    Clinical examination and multimodal imaging used to correlate with pathologically confirmed high grade dysplasia and early carcinoma.


Secondary Outcome Measures :
  1. Lesion Progression [ Time Frame: 2 years ]
    Progression defined as lesions which develop histologic evidence of severe dysplasia, CIS, or cancer.

  2. Lesion Progression [ Time Frame: 2 years ]
    Progression defined as lesions which progress by two or more grades on the continuum from normal to hyperplasia to mild dysplasia to moderate dysplasia to severe dysplasia to CIS to cancer.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects 18 years and older who are willing to participate.
  2. Adult subjects with: a. clinically evident 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.
  3. Ability to understand and willingness to sign a written Informed Consent Document (ICD).

Exclusion Criteria:

  1. Subjects under the age of 18
  2. Known allergy to proflavine or acriflavine
  3. Pregnant females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790853


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)
William Marsh Rice University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ann M. Gillenwater, MD, BA M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02790853     History of Changes
Other Study ID Numbers: 2014-0831
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by M.D. Anderson Cancer Center:
Cancer of Head and Neck
Oral Potentially Malignant Disorders
Suspicious oral mucosal lesion
History of resected oral cancer
OPMD
Multimodal Imaging
Pathologic diagnosis of dysplasia
White Light Examination
WL
Wide-field auto-fluorescence imaging device PS2.1/PS3
Proflavine Hemisulfate
High-Resolution Optical System
HRME
Brush Biopsy
Tissue Biopsy

Additional relevant MeSH terms:
Disease
Head and Neck Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents