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

Lung Cancer Clinical Trial

— OCT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01039311
• Other study ID #: 14370
• Status: Terminated
• Phase: N/A
• First received: December 11, 2009
• Last updated: January 31, 2013
• Start date: February 2009
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Optical Coherence Tomography
Obtain OCT images.

Locations

Country	Name	City	State
United States	OU Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT image sensitivity and specificity in diagnosis of lung cancer.		Every 3 months	No
Secondary	Feasibility and safety of obtaining OCT images during flexible bronchoscopy.		Every 3 months	Yes