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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01039311

Acronym

OCT

Enrollment

Registered

2009-12-24

Start date

2009-02-28

Completion date

2012-09-30

Last updated

2013-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung, cancer, bronchoscopy, optical, coherence, tomography

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.

Interventions

DEVICEOptical Coherence Tomography

Obtain OCT images.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
OCT image sensitivity and specificity in diagnosis of lung cancer.	Every 3 months

Secondary

Measure	Time frame
Feasibility and safety of obtaining OCT images during flexible bronchoscopy.	Every 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026