Back to resultsConfocal Laser Microlaryngoscopy (CLMx)
Primary Purpose
Laryngeal Dysplasia, Laryngeal Neoplasm
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluorescein injection, USP 10%
Confocal laser microlaryngoscopy
Biopsy (standard of care)
KTP laser photoablation (standard of care)
Sponsored by
About this trial
This is an interventional diagnostic trial for Laryngeal Dysplasia
Eligibility Criteria
Inclusion Criteria:
- Patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy.
- Patient will have vocal fold leukoplakia or other abnormal epithelial changes.
- Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
- Patient must not have a history of radiation to the neck.
- Patient must not have a documented reaction to fluorescein
- Patient must not have a previous history of laryngeal cancer.
- Patient must not have a history of allergy or bronchial asthma.
- Patient must not be pregnant or breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: CLM
Arm Description
On the day of surgery, participants will have placement of laser-safe endotracheal tube and a rigid laryngoscope will be introduced into the oral cavity to gain access to the laryngeal introitus and then placed into suspension (standard of care) Fluorescein dye will be administered intravenously Confocal laser probe will be introduced through the rigid laryngoscope and touched first on the lesion of concern and put into scanning mode in order to obtain photos and video footage of the lesions. The probe will then be placed on normal appearing vocal fold tissue to obtain a control sample. The remainder of the procedure is standard excisional biopsy and KTP laser photoablation
Outcomes
Primary Outcome Measures
Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe
Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe
Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe
-If the prevalence of the disease in the population is known, the accuracy of the test can be calculated bases on prevalence sensitivity, specificity using the formula: Sensitivity*Prevalence + Specificity*(1-Prevalence)
Secondary Outcome Measures
Full Information
NCT ID
NCT02628496
First Posted
December 9, 2015
Last Updated
September 8, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02628496
Brief Title
Confocal Laser Microlaryngoscopy (CLMx)
Official Title
Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Lost funding/staff
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions.
In order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. While in the operating room, prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard protocol, and the diagnostic results from CLM and the formal biopsy will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Dysplasia, Laryngeal Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: CLM
Arm Type
Experimental
Arm Description
On the day of surgery, participants will have placement of laser-safe endotracheal tube and a rigid laryngoscope will be introduced into the oral cavity to gain access to the laryngeal introitus and then placed into suspension (standard of care)
Fluorescein dye will be administered intravenously
Confocal laser probe will be introduced through the rigid laryngoscope and touched first on the lesion of concern and put into scanning mode in order to obtain photos and video footage of the lesions. The probe will then be placed on normal appearing vocal fold tissue to obtain a control sample.
The remainder of the procedure is standard excisional biopsy and KTP laser photoablation
Intervention Type
Drug
Intervention Name(s)
Fluorescein injection, USP 10%
Other Intervention Name(s)
AK-FLUOR
Intervention Description
-2.5 ml intravenous 10 minutes before procedure
Intervention Type
Device
Intervention Name(s)
Confocal laser microlaryngoscopy
Other Intervention Name(s)
CLM, CLMx
Intervention Type
Procedure
Intervention Name(s)
Biopsy (standard of care)
Intervention Type
Procedure
Intervention Name(s)
KTP laser photoablation (standard of care)
Primary Outcome Measure Information:
Title
Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe
Time Frame
Day of surgery (Day 1)
Title
Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe
Time Frame
Day of surgery (Day 1)
Title
Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe
Description
-If the prevalence of the disease in the population is known, the accuracy of the test can be calculated bases on prevalence sensitivity, specificity using the formula: Sensitivity*Prevalence + Specificity*(1-Prevalence)
Time Frame
Day of surgery (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy.
Patient will have vocal fold leukoplakia or other abnormal epithelial changes.
Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
Patient must not have a history of radiation to the neck.
Patient must not have a documented reaction to fluorescein
Patient must not have a previous history of laryngeal cancer.
Patient must not have a history of allergy or bronchial asthma.
Patient must not be pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Bradley, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Confocal Laser Microlaryngoscopy (CLMx)
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