Confocal Laser Microlaryngoscopy (CLMx)

NCT ID: NCT02628496

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-01-31

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.

Conditions

Laryngeal Dysplasia; Laryngeal Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fluorescein injection, USP 10%

Intervention Type: DRUG

-2.5 ml intravenous 10 minutes before procedure

Confocal laser microlaryngoscopy

Intervention Type: DEVICE

Biopsy (standard of care)

Intervention Type: PROCEDURE

KTP laser photoablation (standard of care)

Intervention Type: PROCEDURE

Interventions

Fluorescein injection, USP 10%

-2.5 ml intravenous 10 minutes before procedure

Intervention Type: DRUG

Confocal laser microlaryngoscopy

Intervention Type: DEVICE

Biopsy (standard of care)

Intervention Type: PROCEDURE

KTP laser photoablation (standard of care)

Intervention Type: PROCEDURE

Other Intervention Names

AK-FLUOR; CLM; CLMx

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Bradley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201503127

Identifier Type: -

Identifier Source: org_study_id