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

NCT01269190 | Recruiting FDA Drug

• 2 other identifiers: 2008-0613NCI-2015-01904
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cavity Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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.

  Images obtained will be compared against the histology slides of tissue taken from the same region.

  1 day

• Classification of tissue

  Classification algorithms will be developed to separate imaged tissue into 2 diagnostic categories: normal non-neoplastic mucosa vs. dysplasia and cancer

  1 day

Secondary Outcomes (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

  1 day

• Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions

  1 day

Study Arms (1)

Diagnostic (widefield multispectral imaging and HRME)

EXPERIMENTAL

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; Procedure: Multispectral Imaging; Drug: Proflavine

Interventions

High-Resolution Microendoscopy PROCEDURE

Undergo evaluation of oral lesions using a high-resolution microendoscope

Also known as: HRME

Diagnostic (widefield multispectral imaging and HRME)

Multispectral Imaging PROCEDURE

Undergo evaluation of oral cavity using a widefield multispectral imaging

Diagnostic (widefield multispectral imaging and HRME)

Proflavine DRUG

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

Also known as: Proflavine hemisulfate

Diagnostic (widefield multispectral imaging and HRME)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Proflavine

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ann Gillenwater

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Gillenwater

CONTACT

713-792-8841; agillenw@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 4, 2011
• Study Start: December 30, 2010
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)