Confocal Laser Microlaryngoscopy (CLMx)

NCT02628496 | Withdrawn

• 1 other identifier: 201503127
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Arm 1: CLM

EXPERIMENTAL

* 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%; Device: Confocal laser microlaryngoscopy; Procedure: Biopsy (standard of care); Procedure: KTP laser photoablation (standard of care)

Interventions

Fluorescein injection, USP 10% DRUG

-2.5 ml intravenous 10 minutes before procedure

Also known as: AK-FLUOR

Arm 1: CLM

Confocal laser microlaryngoscopy DEVICE

Also known as: CLM, CLMx

Arm 1: CLM

Biopsy (standard of care) PROCEDURE

Arm 1: CLM

KTP laser photoablation (standard of care) PROCEDURE

Arm 1: CLM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Fluorescein; Fluoresceins; Biopsy; Standard of Care

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Joseph Bradley, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 11, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share