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

This study has been terminated.
(Unable to enroll subjects)
Sponsor:
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01039311
First received: December 11, 2009
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Lung Cancer
 Device: Optical Coherence Tomography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • OCT image sensitivity and specificity in diagnosis of lung cancer. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility and safety of obtaining OCT images during flexible bronchoscopy. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: February 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Optical Coherence Tomography
Examine OCT images and compare them to conventional biopsies in same subject.
 Device: Optical Coherence Tomography
Obtain OCT images.
Other Name: Imalux Niris

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039311

Locations
United States, Oklahoma
OU Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Jean Keddissi, MD University of Oklahoma
  More Information

No publications provided by University of Oklahoma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01039311     History of Changes
Other Study ID Numbers: 14370
Study First Received: December 11, 2009
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
Lung
cancer
bronchoscopy
 optical
coherence
tomography

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013