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

August 26, 2009
February 8, 2011
June 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00966511 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Lung Cancer
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.
Lung resection candidates
Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Intervention: Procedure: Lung resection surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00966511
DB041
Yes
Merav Gat / VP Clinical Affairs, Deep Breeze
Deep Breeze
Not Provided
Principal Investigator: Frank C Detterbeck, MD Yale University Medical School
Deep Breeze
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP