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Trial record 9 of 200 for:    Oral Cancer | Recruiting Studies | NIH

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

  Show Detailed Description

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

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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