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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01039311
Recruitment Status : Terminated (Unable to enroll subjects)
First Posted : December 24, 2009
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma

Brief Summary:
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.

Condition or disease Intervention/treatment
Lung Cancer Device: Optical Coherence Tomography

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
Actual Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer
Study Start Date : February 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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 Name: Imalux Niris

Primary Outcome Measures :
  1. OCT image sensitivity and specificity in diagnosis of lung cancer. [ Time Frame: Every 3 months ]

Secondary Outcome Measures :
  1. Feasibility and safety of obtaining OCT images during flexible bronchoscopy. [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients ages 18-99 with the presence of of an endobronchial mass.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01039311

United States, Oklahoma
OU Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Jean Keddissi, MD University of Oklahoma

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma Identifier: NCT01039311     History of Changes
Other Study ID Numbers: 14370
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Gary Kinasewitz, University of Oklahoma:

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases