Confocal Laser Microlaryngoscopy (CLMx)

Not Applicable

Withdrawn

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

• Registration Number: NCT02628496
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: CLM	Fluorescein injection, USP 10%	* 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
Arm 1: CLM	Confocal laser microlaryngoscopy	* 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
Arm 1: CLM	Biopsy (standard of care)	* 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
Arm 1: CLM	KTP laser photoablation (standard of care)	* 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

Primary Outcome Measures

Name	Time	Method
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	Day of surgery (Day 1)	-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)
Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe	Day of surgery (Day 1)