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

University of Oklahoma16 enrolled

Overview

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.

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

Conditions

Lung Cancer

Interventions

Optical Coherence TomographyDEVICE

Obtain OCT images.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

OU Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

OCT image sensitivity and specificity in diagnosis of lung cancer.

Time frame: Every 3 months

Secondary Outcomes

Feasibility and safety of obtaining OCT images during flexible bronchoscopy.

Time frame: Every 3 months

Data from ClinicalTrials.gov

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