Confocal Laser Microlaryngoscopy (CLMx)

Laryngeal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02628496
• Other study ID #: 201503127
• Status: Withdrawn
• Phase: N/A
• First received: December 9, 2015
• Last updated: September 8, 2016
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: September 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Laryngeal Dysplasia
• Laryngeal Neoplasm
• Laryngeal Neoplasms

Intervention

Drug:
• Fluorescein injection, USP 10%
-2.5 ml intravenous 10 minutes before procedure

Device:
• Confocal laser microlaryngoscopy

Procedure:
• Biopsy (standard of care)

• KTP laser photoablation (standard of care)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe		Day of surgery (Day 1)	No
Primary	Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe		Day of surgery (Day 1)	No
Primary	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)	No

External Links

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