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Trial record 23 of 2103 for:    Oral Cancer | NIH

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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oral Cavity Neoplasm Procedure: High-Resolution Microendoscopy Procedure: Multispectral Imaging Drug: Proflavine Early Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: Proflavine
Proflavine) used to stain the mouth tissue after initial imaging.
Other Name: Proflavine hemisulfate




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01269190


Contacts
Contact: Ann Gillenwater 713-792-8841 agillenw@mdanderson.org

Locations
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         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ann Gillenwater M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01269190     History of Changes
Other Study ID Numbers: 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 )
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents