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Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT01269190
Recruitment Status : Recruiting
First Posted : January 4, 2011
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

December 30, 2010
January 4, 2011
September 21, 2018
December 30, 2010
December 31, 2018   (Final data collection date for primary outcome measure)
  • 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
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 ]
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.
Complete list of historical versions of study NCT01269190 on ClinicalTrials.gov Archive Site
  • 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.
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 ]
Several images of oral cavity mucosa taking approximately two minutes or less each, and removal for pathologic analysis of the measured sites
Not Provided
Not Provided
 
Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery
Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study
This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.

Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Oral Cavity Neoplasm
  • 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
  • Drug: Proflavine
    Proflavine) used to stain the mouth tissue after initial imaging.
    Other Name: Proflavine hemisulfate
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.
Interventions:
  • Procedure: High-Resolution Microendoscopy
  • Procedure: Multispectral Imaging
  • Drug: Proflavine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
275
35
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Ann Gillenwater 713-792-8841 agillenw@mdanderson.org
United States
 
 
NCT01269190
2008-0613
NCI-2015-01904 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2008-0613 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Ann Gillenwater M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP