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

University of Oklahoma (OU)

Status: Terminated

Conditions: Lung Cancer

Treatments: Device: Optical Coherence Tomography

Study type: Observational

Funder types: Other

Identifiers

NCT01039311

14370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

16 participants in 1 patient group

Optical Coherence Tomography

Description:

Examine OCT images and compare them to conventional biopsies in same subject.

Treatment:

Device: Optical Coherence Tomography