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Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

This study is enrolling participants by invitation only.
Information provided by University of California, Irvine

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Descriptive Information Fields
Brief Title  Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract
Official Title  Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract
Brief Summary

At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call 'Optical Coherence tomography (OCT)'.

OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology.

Optical coherence tomography (OCT) is an emerging imaging modality that uses light to image turbid media such as living tissues, and has been successfully used to generate high resolution cross-sectional images of tissue microstructure in the human retina and skin.

We have developed a multi-purpose OCT system for use in imaging the larynx, esophagus, trachea, oral cavity and nasal cavity with the overall objective of evaluating the efficacy of using OCT to image the microstructure of these organs. The OCT imaging system has image tissues of the aero-digestive tract during surgical endoscopy,the nose, oral cavity,larynx in an outpatient clinic setting. Knowledge of vocal cord, esophageal, tracheal, oral cavity, and nasal epithelial/mucosal microstructure would be extremely valuable in the treatment and diagnosis of both benign and malignant diseases of the upper aero-digestive tract, and at present there are no reliable techniques which provide this information with this degree of resolution other than a biopsy.

Detailed Description

This study involves the collection of data through a noninvasive means in patients who are undergoing laryngeal, oral cavity, esophageal, tracheal, and nasal endoscopy for other medically indicated reasons. During laryngeal surgical endoscopy, the data obtained will not be used for patient care. Images will also be obtained using a surgical laryngoscope thru which an OCT imaging fiber is placed.

The device focuses low power non-laser broad band infrared light onto laryngeal, esophageal, tracheal, oral and nasal tissue and does not involve input of significant amounts of energy into the subject; no temperature rise occurs. In this respect, it is quite similar to other diagnostic imaging techniques as well as other UCI IRB approved protocols (at least one of which is approved as expedited) involving near-infrared light. Because there is no direct contact of the device with the subject, and because the wavelength of light used for imaging does not have adverse tissue effects, there is no increase in risk over and above the risk the subject already accepts while undergoing general anesthesia or sedation.

Study Phase
Study Type  Observational
Study Design  Case-Only, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Upper Areo-Digestive Tract
Intervention  Device: OCT
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Enrolling by invitation
Enrollment  400
Start Date  August 2003
Completion Date June 2012
Eligibility Criteria 

Inclusion Criteria:

  • Male and female age from new born to all age

Exclusion Criteria:

  • subject who do not sign consent form
Gender Both
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00544427
Organization ID RR-01192, DC-06026
Secondary IDs †† 12RT-0113, P41-RR01192;NIH-LAMMP
Study Sponsor  University of California, Irvine
Collaborators †† Beckman Laser Institute Medical Clinic
Investigators 
Principal Investigator:     Brian JF Wong, M.D.,Ph.D.     Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine    
Information Provided By University of California, Irvine
Verification Date May 2008
First Received Date  October 12, 2007
Last Updated Date May 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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