Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Resolution Microendoscopy, Multispectral Imaging, Proflavine.
- Who it may be relevant to
- Registry conditions: Oral Cavity Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study
Overview
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.
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.
Interventions
- Procedure High-Resolution Microendoscopy
Undergo evaluation of oral lesions using a high-resolution microendoscope - 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.
Primary outcome measures
- 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]
- Classification of tissue [Time frame: 1 day]
Secondary outcome measures (2)
- 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]
- Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions [Time frame: 1 day]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT01269190 · 2008-0613 · NCI-2015-01904 · 2008-0613