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18 Years
Open (Enrolling)
Squamous Cell Lung Cancer, Lung Cancer

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Trial Information

The prevalence and high mortality rate associated with lung squamous cell carcinoma and the
lack of any widely accepted screening and surveillance tools, highlights the need for new
imaging paradigms that will ultimately lead to a reduction in patient mortality.

Bronchial carcinoma-in-situ will progress to invasive cancer in over 40% of individuals, and
although the progression occurs over a long period of time, the majority of carcinomas are
detected in the later stages of disease development, offering patients only a slim chance of
cure. Although significant effort in the development of screening paradigms for the
detection of lung cancer in the central airways have been made, to date there is still no
widely accepted and validated approach. Optical frequency domain imaging (OFDI) is a recent
derivative of optical coherence tomography (OCT). OFDI can be used to conduct volumetric
microscopy of the airways at a resolution comparable with architectural histopathology. The
long term goal of this study is to use OFDI to screen the airways with the hope of detecting
squamous cell carcinoma at an early more curable stage.

Standard of care bronchoscopy preparation and procedures will be followed including moderate
sedation, pulse oximetry and blood pressure monitoring as per department protocol. A
combination of currently approved bronchoscopy techniques including standard white light
bronchoscopy, autofluorescence bronchoscopy, and narrow band imaging will be used to assess
the airways. Bronchial regions of interest (ROI) suspected to be premalignant or malignant,
will be imaged using the OFDI system and catheter prior to biopsy acquisition. It is
anticipated that a minimum of 3 OFDI-biopsy correlated pairs from each study participant
will be obtained. An additional OFDI and biopsy will be obtained from a normal ROI. It is
expected that the experimental procedure will add less than 10 minutes to the total length
of the bronchoscopy procedure, but a stopping rule will be instituted to ensure that the
experimental procedure does not exceed 20 minutes.

Inclusion Criteria:

- Patients undergoing bronchoscopy for known or suspected pulmonary malignancy in the
central airways

- Patients must be over the age of 18

- Patient must be able to give informed consent

- Women with child bearing potential must have a negative pregnancy test within seven
days prior to the procedure

Exclusion Criteria:

- Systolic blood pressure less than 90

- SPO2 (Oxygen saturation measured by pulse oximetry) less than 80% on FiO2 greater
than 70%

- Active bronchospasm

- Recent myocardial infarction within last two weeks

- Active cardiac chest pain

- Significant untreated sleep apnea

- In active respiratory failure

- Patients who require intubation for airway stabilization

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Principal Investigator

Melissa J Suter, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

December 2014

Related Keywords:

  • Squamous Cell Lung Cancer
  • Lung Cancer
  • Optical Frequency Domain Imaging
  • Optical Coherence Tomography
  • Optical biopsy
  • Comprehensive Microscopy
  • Lung Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617