Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00966511
First received: August 26, 2009
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

The primary purpose of the study is to investigate the use of VRI to guide the selection of patients for lung surgery. Perfusion scintigraphy is the current method to assess the fractional contribution of lung function of the remaining lung.

The hypothesis is that VRI can determine quantitative postoperative lung function equally accurately as a quantitative perfusion scan.


Condition Intervention
Lung Cancer
Procedure: Lung resection surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection

Resource links provided by NLM:


Further study details as provided by Deep Breeze:

Primary Outcome Measures:
  • Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan [ Time Frame: Prior to surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lung resection candidates
Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Procedure: Lung resection surgery
The study is designed in a way that will not alter the surgeon's decision based on routine assessment of candidates for resection (lobectomy or greater). Namely, the VRI data will be gathered prospectively; however, the analyses using VRI data will be performed retrospectively.

Detailed Description:

Primarily, VRI will be compared to perfusion (Q) scan by predicted post-operative (ppo) FEV1 and DLCO as predicted by VRI versus as predicted by Q scan. Secondary, the ppo as predicted by each test will be compared with the actual FEV1 and DLCO at 3 months post-operative; If these two methods provide similar results, VRI will be deemed an acceptable alternative to Q scan for determining patient selection for lung resection. Finally, the patient outcomes (30 day mortality and pulmonary complications) for those patients falling within guideline parameters using the VRI measurement will be analyzed to see if using VRI in clinical practice would indeed allow prediction of satisfactory results (similar to literature benchmarks).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study participants will be patients who are candidates for lung resection (lobectomy or greater)

Criteria

Inclusion Criteria:

  1. Able and willing to read, understand, and provide written Informed Consent;
  2. Age range of 18-90 years;
  3. Potential candidate for at least lobectomy due to lung cancer or other intrathoracic malignancy (either suspected or proven by biopsy). Both open and minimally invasive (thoracoscopic) resections are acceptable.
  4. BMI > 19.

Exclusion Criteria:

  1. Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
  2. There should be no active pulmonary infection (e.g. pneumonia) at the time of the recordings;
  3. Hirsutism unless patient is willing to have back shaved;
  4. Potentially contagious skin lesion on the back;
  5. Giant bulla (more than 1/3 of the hemithorax or >10cm)
  6. Pregnant women
  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: NCT00966511

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8062
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Boston Medical Center, Boston University
Boston, Massachusetts, United States, 02118
United States, New York
Mt. Sinai School of Medicine
New York, New York, United States, 10029
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Deep Breeze
Investigators
Principal Investigator: Frank C Detterbeck, MD Yale University Medical School
  More Information

Publications:
Responsible Party: Merav Gat / VP Clinical Affairs, Deep Breeze
ClinicalTrials.gov Identifier: NCT00966511     History of Changes
Other Study ID Numbers: DB041
Study First Received: August 26, 2009
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Deep Breeze:
lung cancer
lung resection
lobectomy
pneumonectomy
lung function
perfusion

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 September 16, 2014