Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01269190|
Recruitment Status : Recruiting
First Posted : January 4, 2011
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oral Cavity Neoplasm||Procedure: High-Resolution Microendoscopy Procedure: Multispectral Imaging Drug: Proflavine||Early Phase 1|
I. To evaluate the feasibility for assessing oral mucosa in vivo 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.
II. To develop and evaluate algorithms to classify tissue as normal (including hyperkeratosis, hyperplasia, and inflammation) or abnormal (any grade of dysplasia or cancer) based on quantitative parameters extracted from the optical images.
I. To determine the percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye.
II. To identify qualitative and quantitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions.
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (high-resolution microendoscope [HRME]) at baseline, after induction of general anesthesia, and prior to surgery.
After completion of study, patients are followed up for 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||275 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study|
|Actual Study Start Date :||December 30, 2010|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Diagnostic (widefield multispectral imaging and HRME)
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.
Procedure: High-Resolution Microendoscopy
Undergo evaluation of oral lesions using a high-resolution microendoscope
Other Name: HRME
Procedure: Multispectral Imaging
Undergo evaluation of oral cavity using a widefield multispectral imaging
Proflavine) used to stain the mouth tissue after initial imaging.
Other Name: Proflavine hemisulfate
- Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine. [ Time Frame: 1 day ]Images obtained will be compared against the histology slides of tissue taken from the same region.
- Classification of tissue [ Time Frame: 1 day ]Classification algorithms will be developed to separate imaged tissue into 2 diagnostic categories: normal non-neoplastic mucosa vs. dysplasia and cancer
- Percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye [ Time Frame: 1 day ]The data analysis will be descriptive and exploratory in nature. The potential association between sites within the same subject will be examined as well. Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.
- Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions [ Time Frame: 1 day ]Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.
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): NCT01269190
|Contact: Ann Gillenwaterfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ann M. Gillenwater 713-792-8841|
|Principal Investigator: Ann M. Gillenwater|
|Principal Investigator:||Ann Gillenwater||M.D. Anderson Cancer Center|