Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
NCT ID: NCT01816841
Last Updated: 2020-01-30
Study Results
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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COMPLETED
NA
68 participants
INTERVENTIONAL
2008-11-11
2019-12-28
Brief Summary
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Detailed Description
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I. To assess the diagnostic benefit of the VELscope (direct visual fluorescence) inspection in oral examination.
II. Efficacy of the VELscope in identifying dysplastic (premalignant) and malignant oral mucosal lesions and in discriminating these lesions from common benign tissue changes.
III. Accuracy of clinical judgment versus VELscope findings. IV. Ability of the VELscope to identify lesions or extent of lesions beyond what is clinically apparent.
OUTLINE:
Patients undergo conventional oral examination (COE) followed by direct visual fluorescence examination (DVFE). Patients with tissue abnormalities found by COE or DVFE undergo scalpel biopsy within 2 weeks.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (COE and DVFE)- Arm I
Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.
fluorescence imaging
Undergo DVFE
biopsy
Undergo scalpel biopsy
examination
Undergo COE
Arm II - Comparison of surgical margins using COE vs. DVFE
Comparison of surgical margins using COE vs. DVFE
fluorescence imaging
Undergo DVFE
biopsy
Undergo scalpel biopsy
examination
Undergo COE
Comparison of surgical margins by COE vs. DVFE
Surgical margin determination using DVFE
Interventions
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fluorescence imaging
Undergo DVFE
biopsy
Undergo scalpel biopsy
examination
Undergo COE
Comparison of surgical margins by COE vs. DVFE
Surgical margin determination using DVFE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 33 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:
* 250 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
18 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Kristin McNamara
Principal Investigator
Principal Investigators
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Kristin McNamara, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2012-02017
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-08095
Identifier Type: -
Identifier Source: org_study_id
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