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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-30

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oral Cavity Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High-Resolution Microendoscopy

Intervention Type PROCEDURE

Undergo evaluation of oral lesions using a high-resolution microendoscope

Multispectral Imaging

Intervention Type PROCEDURE

Undergo evaluation of oral cavity using a widefield multispectral imaging

Proflavine

Intervention Type DRUG

Proflavine) used to stain the mouth tissue after initial imaging.

Interventions

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High-Resolution Microendoscopy

Undergo evaluation of oral lesions using a high-resolution microendoscope

Intervention Type PROCEDURE

Multispectral Imaging

Undergo evaluation of oral cavity using a widefield multispectral imaging

Intervention Type PROCEDURE

Proflavine

Proflavine) used to stain the mouth tissue after initial imaging.

Intervention Type DRUG

Other Intervention Names

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HRME Proflavine hemisulfate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No