Clinical trial NCT01039311: Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer
Official title: Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: Lung
cancer
bronchoscopy
optical
coherence
tomography
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ages 18-99 with the presence of of an endobronchial mass.

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.

Eligibility criteria: 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

Primary outcomes:
measure: OCT image sensitivity and specificity in diagnosis of lung cancer.
timeFrame: Every 3 months
Secondary outcomes:
measure: Feasibility and safety of obtaining OCT images during flexible bronchoscopy.
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Jean Keddissi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michel RG, Kinasewitz GT, Fung KM, Keddissi JI. Optical coherence tomography as an adjunct to flexible bronchoscopy in the diagnosis of lung cancer: a pilot study. Chest. 2010 Oct;138(4):984-8. doi: 10.1378/chest.10-0753. Epub 2010 May 14.