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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-09-30

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.

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Optical Coherence Tomography

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

Optical Coherence Tomography

Intervention Type DEVICE

Obtain OCT images.

Interventions

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Optical Coherence Tomography

Obtain OCT images.

Intervention Type DEVICE

Other Intervention Names

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Imalux Niris

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No