Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

The study seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a Doppler mode is placed on the chest wall and the unique software the investigators have developed analyzes the signals reflected from within the lung. On the basis of of pilot studies performed previously the investigators expect to receive different signals from different diseases that will enable diagnosis of different lung diseases.

Study Overview

• Status: Terminated
• Conditions: Lung Disease, Chronic Obstructive; Lung Disease, Interstitial

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States
      • outpatient pulmonary clinics, University of Maryland Medical school hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients are referred to the outpatient pulmonary clinics or PFT lab for further workup

Description

Inclusion Criteria:

• Able and willing to provide informed consent
• Age 18 years or older
• Clinic and hospital records including additional background medical data such as results of echocardiograms, cardiac catheterization pathology reports etc., available and accessible.
• Evaluation by a physician who determines that a High Resolution Computed Tomography (HRCT) of the Thorax and pulmonary function tests, including spirometry, lung volumes and diffusion capacity, are indicated as part of the standard clinical care.

• If full lung function tests are normal imaging with a regular chest x-ray is sufficient.

  • Study Population - subjects will be grouped based on the following criteria after obtaining pulmonary function tests and HRCT of the thorax -

    1. COPD based on clinical assessment and spirometry showing airflow limitation i.e., (FEV1/FVC < 0.70).
    2. Interstitial lung disease (ILD) diagnosed by HRCT.

    3. Control subjects presenting with pulmonary complaints evaluated by full PFTs (spirometry, lung volume and DLCO) and a chest x-ray and/or HRCT , all found to be within normal limits, .

       Exclusion Criteria:

  • Primary or metastatic lung cancer.
  • Acute pneumonia.
  • Concomitant or previous diagnosis of Bronchial Asthma.
  • Patients with severe chest wall deformity
  • Decompensated heart failure or volume overload.
  • Significant right-sided pleural effusion.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterization of Lung Doppler signals obtained from different lung diseases.	1 year

Collaborators and Investigators

• Sponsor: Echosense Ltd.
• Collaborators: University of Maryland

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 13, 2012

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Chronic obstructive lung disease;; Interstitial lung disease;; Ultrasound Doppler;; Lung disease diagnosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: DOP10