Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

June 15, 2009 updated by: Deep Breeze

The primary objective of this study is to estimate the accuracy of the pre-operative VRI quantitative results versus the gold standard pre-operative perfusion scan.

The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second [FEV1] and diffusing capacity of the lung for carbon monoxide [DLCO]) in patients who underwent surgical resection.

Study Overview

Status

Suspended

Conditions

Detailed Description

Pre lung operation candidates for procedures such as lung volume reduction surgery (LVRS), lung resection, bullectomy and lung transplant are frequently evaluated for differential lung function by a semi quantitative lung scintigraphy. VRI may offer the same differential lung function information for the physician without the risks, time and patient discomfort of lung scintigraphy in the treating physician office.

Moreover, VRI may provide a safe, quick and simple method to measure "split function" in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion "split function" methods.

In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.

Study Type

Observational

Enrollment (Anticipated)

75

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
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients evaluated for lung surgery who will undergo perfusion scan

Description

Inclusion Criteria:

  1. Able and willing to read, understand, and provide written informed consent;
  2. Male or female in the age range of 18-80 years;
  3. Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy.
  4. Body mass index (BMI) > 21.

Exclusion Criteria:

  1. Chest wall deformation;
  2. Spine deformation (including scoliosis);
  3. Hirsutism;
  4. Potentially contagious skin lesion on the back;
  5. Skin lesion that would interfere with sensor placement; (Keloids)
  6. Cardiac pacemaker or implantable defibrillator;

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

Collaborators and Investigators

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

Sponsor

Deep Breeze

Investigators

  • Principal Investigator: Atul C. Mehta, M.D, The Cleveland Clinic

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

September 1, 2007

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

June 16, 2009

Last Update Submitted That Met QC Criteria

June 15, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB032

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.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe