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

March 8, 2019 updated by: Lahey Clinic
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Bronchoscopy
  • Lung tissue biopsy
  • Tissue imaging by Optical Frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Obtain biopsy correlated OFDI images with the purpose of establishing OFDI image criteria for discrimination of tissue types.
Time Frame: One time Bronchoscopy
One time Bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahey Clinic

Collaborators

Massachusetts General Hospital
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Carla R Lamb, M.D., Lahey Clinic, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 31, 2008

First Submitted That Met QC Criteria

October 31, 2008

First Posted (Estimate)

November 2, 2008

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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