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

Terminated

• Conditions: Lung Cancer
• Interventions: Device: Optical Coherence Tomography

• Registration Number: NCT01039311
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Optical Coherence Tomography	Optical Coherence Tomography	Examine OCT images and compare them to conventional biopsies in same subject.

Primary Outcome Measures

Name	Time	Method
OCT image sensitivity and specificity in diagnosis of lung cancer.	Every 3 months

Secondary Outcome Measures

Name	Time	Method
Feasibility and safety of obtaining OCT images during flexible bronchoscopy.	Every 3 months

Trial Locations

Locations (1)

OU Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States