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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Optical Coherence Tomography<br>Examine OCT images and compare them to conventional biopsies in same subject. | Device: Optical Coherence Tomography<br>* Obtain OCT images.<br>* Other names: Imalux Niris;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, cancer, bronchoscopy, optical, coherence, tomography