Confocal Laser Microlaryngoscopy (CLMx)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/29/2016 |
| Start Date: | April 2015 |
| End Date: | January 2017 |
| Contact: | Joseph Bradley, M.D. |
| Email: | bradleyj@ent.wustl.edu |
| Phone: | 314 996-3881 |
Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions
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.
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.
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.
We found this trial at
1
site
St. Louis, Missouri 63108
Principal Investigator: Joseph Bradley, M.D.
Phone: 314-996-3881
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