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


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

OCT image sensitivity and specificity in diagnosis of lung cancer.

Outcome Time Frame:

Every 3 months

Safety Issue:

No

Principal Investigator

Jean Keddissi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Food and Drug Administration

Study ID:

14370

NCT ID:

NCT01039311

Start Date:

February 2009

Completion Date:

September 2012

Related Keywords:

  • Lung Cancer
  • Lung
  • cancer
  • bronchoscopy
  • optical
  • coherence
  • tomography
  • Lung Neoplasms

Name

Location
OU Health Sciences Center Oklahoma City, Oklahoma  73104