Pilot Study to Evaluate Optical Frequency Domain Imaging for Diagnosis of Central Airway Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa J. Suter, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01396603
First received: July 15, 2011
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

This study will evaluate a new imaging technology, termed optical frequency domain imaging (OFDI) for detecting and diagnosing pulmonary malignancy in the central airways.


Condition
Squamous Cell Lung Cancer
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Evaluation of imaging device [ Time Frame: on going ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

Patients referred for bronchoscopy procedures in the Pulmonary and Critical Care Department at Massachusetts General Hospital for the evaluation of known or suspected pulmonary malignancy will be enrolled in this study. Study patients will receive standard of care for pulmonary disease consistent with national guidelines.

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:

  • 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
  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: NCT01396603

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Melissa J Suter, PhD    617-724-7691    msuter@partners.org   
Principal Investigator: Melissa J Suter, PhD         
Sub-Investigator: Colleen L Channick, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Melissa J Suter, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Melissa J. Suter, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01396603     History of Changes
Other Study ID Numbers: 2008P001254, R00CA134920
Study First Received: July 15, 2011
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Optical Frequency Domain Imaging
Optical Coherence Tomography
Optical biopsy
Comprehensive Microscopy

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 October 19, 2014