Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Upper Areo-Digestive Tract |
Device: OCT |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract |
| Estimated Enrollment: | 800 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| diagnostic |
Device: OCT
OCT imaging
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Primary care clinic, and community population
Inclusion Criteria:
- Male and female age from new born to all age
Exclusion Criteria:
- subject who do not sign consent form
Contacts and Locations| United States, California | |
| Beckman Laser Institute medical Clinic,University of California,Irvine | |
| Irvine, California, United States, 92612 | |
| Otolaryngology-Head and Neck Surgery Medical Clinic,University of California,Irvine | |
| Orange, California, United States, 92898 | |
| Principal Investigator: | Brian JF Wong, M.D.,Ph.D. | Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine |
More Information
No publications provided
| Responsible Party: | Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00544427 History of Changes |
| Other Study ID Numbers: | NIH OCT-EB-093-07 |
| Study First Received: | October 12, 2007 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Upper Areo-Digestive tract |
ClinicalTrials.gov processed this record on October 17, 2012
