Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care

NCT01816841 | Completed DMC

• 2 other identifiers: OSU-08095NCI-2012-02017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.

Conditions

Lip and Oral Cavity Squamous Cell Carcinoma; Oral Cavity Verrucous Carcinoma; Stage 0 Lip and Oral Cavity Cancer; Tongue Cancer

Keywords

Direct Visual Fluorescense; Oral Examination; oral cancer

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone

  Will be evaluated by calculating sensitivity and specificity and their corresponding exact 95% confidence intervals. Association between the two techniques will be assessed using the simple kappa statistic.

  At the time of examination

• Differences between lesional margins identified by COE and DVFE

  Will be evaluated using the dependent t-test. In the event that the parametric requirements of this test are not met, the Wilcoxon, matched-pairs, signed-ranks test will be used.

  At the time of examination

Study Arms (2)

Diagnostic (COE and DVFE)- Arm I

EXPERIMENTAL

Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.

Procedure: fluorescence imaging; Procedure: biopsy; Procedure: examination

Arm II - Comparison of surgical margins using COE vs. DVFE

EXPERIMENTAL

Comparison of surgical margins using COE vs. DVFE

Procedure: fluorescence imaging; Procedure: biopsy; Procedure: examination; Procedure: Comparison of surgical margins by COE vs. DVFE

Interventions

fluorescence imaging PROCEDURE

Undergo DVFE

Arm II - Comparison of surgical margins using COE vs. DVFE; Diagnostic (COE and DVFE)- Arm I

biopsy PROCEDURE

Undergo scalpel biopsy

Also known as: biopsies

Arm II - Comparison of surgical margins using COE vs. DVFE; Diagnostic (COE and DVFE)- Arm I

examination PROCEDURE

Undergo COE

Also known as: Exam, Medical Assessment, Medical Exam, Medical Examination, Medical Inspection

Arm II - Comparison of surgical margins using COE vs. DVFE; Diagnostic (COE and DVFE)- Arm I

Comparison of surgical margins by COE vs. DVFE PROCEDURE

Surgical margin determination using DVFE

Arm II - Comparison of surgical margins using COE vs. DVFE

Eligibility Criteria

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

You may qualify if:

• HIGH-RISK POPULATION:
• consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
• GENERAL POPULATION:
• consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia; Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Tongue Neoplasms

Interventions

Optical Imaging; Biopsy; Restraint, Physical; Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Behavior Control; Therapeutics; Immobilization; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Kristin McNamara, DDS, MS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: November 11, 2008
• Primary Completion: October 3, 2016
• Study Completion: December 28, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)