Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer (OCT)

January 31, 2013 updated by: Gary Kinasewitz, University of Oklahoma
Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OCT could become a powerful tool in diagnostic pulmonary medicine, not only in the early recognition of lung cancer, but also in the evaluation and monitoring of microstructures in the lower respiratory tract that are affected by other inflammatory or invasive disease processes. Initially, OCT could be used to guide the location of biopsies which would likely provide increased specificity to traditional bronchoscopy. However, if the sensitivity and specificity of OCT images are comparable to histologic specimens, this technology may in the future provide a non-invasive "optical biopsy", which could potentially obviate the need for conventional biopsies in patients with high risks for complications, such as bleeding.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients ages 18-99 with the presence of of an endobronchial mass.

Description

Inclusion Criteria:

  • Subjects 18-99 years of age
  • Presence of an endobronchial mass
  • Need for flexible bronchoscopy, with endobronchial biopsies

Exclusion Criteria:

  • PCO2 > 47 mm Hg, and/or long term Oxygen therapy
  • Unwillingness to undergo fiberoptic bronchoscopy
  • Coagulopathy, defined as a platelets count < 100.000/mm3, or an INR> 1.4, or known clinical bleeding disorder
  • Therapy with anticoagulant, including Coumadin and Clopidogrel
  • Renal dysfunction, defined as a Creatinine > 2 mg/dl
  • Life-threatening arrhythmias, or history of myocardial infarction within 6 months
  • Cerebrovascular Accident within the preceding 6 months
  • Facial abnormality preventing safe introduction of the bronchoscope
  • Uncontrolled hypertension
  • Active liver disease
  • Pregnancy or Breastfeeding
  • Prisoners
  • Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Optical Coherence Tomography
Examine OCT images and compare them to conventional biopsies in same subject.
Device: Optical Coherence Tomography
Obtain OCT images.
Other Names:
  • Imalux Niris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
OCT image sensitivity and specificity in diagnosis of lung cancer.
Time Frame: Every 3 months
Every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Feasibility and safety of obtaining OCT images during flexible bronchoscopy.
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Jean Keddissi, MD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14370

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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