Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00784329
First received: October 31, 2008
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

To evaluate the potential of a new imaging device, termed Optical Frequency Domain Imaging (OFDI), in the early diagnosing of pulmonary malignancies in the central airways.


Condition Intervention
Squamous Cell Lung Cancer
Lung Cancer
Pulmonary Disease
Device: Optical Frequency Domain Imaging (OFDI) System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Obtain biopsy correlated OFDI images with the purpose of establishing OFDI image criteria for discrimination of tissue types. [ Time Frame: One time Bronchoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2008
Estimated Study Completion Date: March 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optical Frequency Domain Imaging
Optical Frequency Domain Imaging System used during Lung and Bronchial biopsies to detect cancerous tissue. Tissue imaging results will be compared to tissue biopsy results.
Device: Optical Frequency Domain Imaging (OFDI) System
Optical Frequency Domain Imaging(OFDI)System. Additional biopsy obtained from regions of normal appearing tissue. Up to an additional 20 minutes to standard Bronchoscopy
Other Names:
  • Lung tissue biopsy
  • Tissue imaging by Optical Frequency
  • Bronchoscopy

Detailed Description:

This study will evaluate the potential of a new imaging device, the Optical Frequency Domain Imaging (OFDI) for imaging pulmonary malignancy in the central airways.

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 very slim chance of cure. Although, significant effort in the development of screening paradigms for the detection of lung cancer in the central airway has 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). As in OCT, OFDI is an interferometric ranging technique that can roughly be considered to be an optical analogue of ultrasound imaging and can provide tomographic images of tissue at resolutions comparable with architectural histology. 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 earlier more curable stage.

Standard of care bronchoscopy preparation and procedures to be followed, with moderate sedation, pulse oximetry and blood pressure monitoring as per department protocol. A combination of currently approved bronchoscopy techniques including stand white light bronchoscopy, autofluorescence bronchoscopy, and narrow band imaging will be used to assess the airways.

Bronchial regions of interest (ROI's)suspected to be premalignant or malignant, identified during the bronchoscopy procedure, will be imaged using the OFDI system and catheter before biopsy is done. It is anticipated to obtain a minimum of 3 OFDI-biopsy correlated pairs from each study participant. An additional OFDI image and biopsy will be obtained from region's of normal interest (ROI's). 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • PaO2 less than 80 on FiO2 greater 70%
  • Systolic blood pressure less than 90
  • Active bronchospasm
  • INR greater than 2.0 (INR: International Normalized Ratio)
  • Recent myocardial infarction within last two weeks
  • Active cardiac chest pain
  • Significant untreated sleep apnea
  • FEV1 less than 30% of predicted (FEV1: forced expiratory volume in 1 second)
  • Worsening hypercarbia with PaCO2 greater than 55
  • In active respiratory failure (unless endotracheal intubation is performed first to stabilize the airway)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784329

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Massachusetts General Hospital
Investigators
Principal Investigator: Anthony W Bonhert, M.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00784329     History of Changes
Other Study ID Numbers: 2008-031
Study First Received: October 31, 2008
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lahey Clinic:
Lung Cancer
Squamous Cell Lung Cancer
Bronchial carcinoma in situ
Central Airway Diseases

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

ClinicalTrials.gov processed this record on September 16, 2014