Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

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PostaveníDokončeno

Sponzoři

Icahn School of Medicine at Mount Sinai

Spolupracovníci

William Marsh Rice University

KLINICKÉ HODNOCENÍ: NCT01321892

BioSeek: NCT01321892

Klíčová slova

Abstraktní

The purpose of this research study is to collect information on whether images made using investigational microscopes can improve researchers' ability to evaluate and distinguish between normal and abnormal areas in tissue samples surgically removed from patients with squamous cell carcinoma. The microscopes being used in this study are considered investigational because they have not been approved by the United States Food and Drug Administration (FDA) for finding abnormal or pre-cancerous areas.

Popis

The overall objective of this exploratory study is to evaluate whether noninvasive fluorescence and reflectance imaging of the upper aerodigestive tract can help clinicians more accurately determine intraoperative margins during ablative cancer surgery. This is an ex vivo study designed to evaluate the feasibility of using prototype optical imaging technology to enhance the discrimination between areas of noncancerous "normal" and cancerous mucosa. The results of this laboratory study will be used to further refine and develop this technology for in vivo application.

Primary Aim:

(1) To collect data to develop imaging algorithms to distinguish between normal and cancerous upper aerodigestive mucosa.

Secondary Aims:

1. To compare the combination of wide-field fluorescence/reflectance and high resolution fluorescence microscopy images of upper aerodigestive epithelium to histopathologic analysis of biopsied tissue.

2. To compare the ability of sequential wide-field/fluorescence microscopy imaging to discriminate between normal and cancerous oral cavity mucosa with that of white-light images obtained after staining with toluidine blue.

Termíny

Poslední ověření:	05/31/2012
První předloženo:	03/20/2011
Odhadovaná registrace vložena:	03/21/2011
První zveřejnění:	03/23/2011
Poslední aktualizace byla odeslána:	06/19/2012
Poslední aktualizace zveřejněna:	06/20/2012
Aktuální datum zahájení studie:	05/31/2009
Odhadované datum dokončení primární:	04/30/2012
Odhadované datum dokončení studie:	04/30/2012

Stav nebo nemoc

Squamous Cell Carcinoma of the Oral Cavity

Oropharynx

Larynx

Hypopharynx

Fáze

Skupiny zbraní

Paže	Intervence / léčba
Squamous cell carcinoma Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.

Kritéria způsobilosti

Věky způsobilé ke studiu	18 Years Na 18 Years
Pohlaví způsobilá ke studiu	All
Metoda vzorkování	Non-Probability Sample
Přijímá zdravé dobrovolníky	Ano
Kritéria	Inclusion Criteria: - Subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx. - Must be receiving surgical treatment for their cancer. Exclusion Criteria: • Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.

Výsledek

Primární výsledná opatření

1. Accuracy and Interrater Reliability of HRME Image Interpretation [baseline]

We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)