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
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)|
|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|
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.
- 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.
- Lesion Progression [ Time Frame: 2 years ]Progression defined as lesions which develop histologic evidence of severe dysplasia, CIS, or cancer.
- 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.
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
|Contact: Ann M. Gillenwater, MD, BA||713-792-8841|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ann M. Gillenwater, MD, BA||M.D. Anderson Cancer Center|