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

NCT01039311 | Terminated DMC

• 1 other identifier: 14370
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung; cancer; bronchoscopy; optical; coherence; tomography

Outcome Measures

Primary Outcomes (1)

• OCT image sensitivity and specificity in diagnosis of lung cancer.

  Every 3 months

Secondary Outcomes (1)

• Feasibility and safety of obtaining OCT images during flexible bronchoscopy.

  Every 3 months

Study Arms (1)

Optical Coherence Tomography

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

Device: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DEVICE

Obtain OCT images.

Also known as: Imalux Niris

Optical Coherence Tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients ages 18-99 with the presence of of an endobronchial mass.

You may qualify if:

• Subjects 18-99 years of age
• Presence of an endobronchial mass
• Need for flexible bronchoscopy, with endobronchial biopsies

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• 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.

  PMID: 20472863 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Jean Keddissi, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 24, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)