Confocal Laser Microlaryngoscopy (CLMx)

The Washington University

Status: Withdrawn

Conditions: Laryngeal Dysplasia; Laryngeal Neoplasm

Treatments: Procedure: Biopsy (standard of care); Drug: Fluorescein injection, USP 10%; Device: Confocal laser microlaryngoscopy; Procedure: KTP laser photoablation (standard of care)

Study type: Interventional

Funder types: Other

Identifiers

NCT02628496

201503127

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Arm 1: CLM

Experimental group

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

Treatment:

Device: Confocal laser microlaryngoscopy

Drug: Fluorescein injection, USP 10%

Procedure: Biopsy (standard of care)

Procedure: KTP laser photoablation (standard of care)