Confocal Laser Microlaryngoscopy (CLMx)

Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions

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.

Study Overview

• Status: Withdrawn
• Conditions: Laryngeal Neoplasm; Laryngeal Dysplasia
• Intervention / Treatment: Drug: Fluorescein injection, USP 10%; Device: Confocal laser microlaryngoscopy; Procedure: Biopsy (standard of care); Procedure: KTP laser photoablation (standard of care)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm 1: CLM; 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

Drug: Fluorescein injection, USP 10%; -2.5 ml intravenous 10 minutes before procedure; Other Names: AK-FLUOR; Device: Confocal laser microlaryngoscopy; Other Names: CLM; CLMx; Procedure: Biopsy (standard of care); Procedure: KTP laser photoablation (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe		Day of surgery (Day 1)
Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe		Day of surgery (Day 1)
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)	Day of surgery (Day 1)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Joseph Bradley, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngeal Neoplasms
• Other Study ID Numbers: 201503127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No