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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Children’s Hospital of Orange County
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00544427
First received: October 12, 2007
Last updated: May 19, 2014
Last verified: May 2014
  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
Disorder of Upper 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

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Pain Blocking During Drug Administration or Blood Collection With Needles [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: August 2003
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Study Population

Primary care clinic, and community population

Criteria

Inclusion Criteria:

  • Male and female age from new born to all age

Exclusion Criteria:

  • subject who do not sign consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544427

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
Children Hospital of Orange
Orange, California, United States, 92868
Sponsors and Collaborators
Montana Compton
Children’s Hospital of Orange County
Investigators
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: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Upper Areo-Digestive tract

ClinicalTrials.gov processed this record on August 21, 2014