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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00966511
• Other study ID #: DB041
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 26, 2009
• Last updated: February 8, 2011
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2011
• Source: Deep Breeze
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Boston Medical Center, Boston University	Boston	Massachusetts
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Mt. Sinai School of Medicine	New York	New York
United States	New York-Presbyterian Hospital/Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Country where clinical trial is conducted

United States, 

References & Publications (6)

Becker HD, Slawik M, Miyazawa T, Gat M. Vibration response imaging as a new tool for interventional-bronchoscopy outcome assessment: a prospective pilot study. Respiration. 2009;77(2):179-94. doi: 10.1159/000182972. Epub 2008 Dec 9. — View Citation

Colice GL, Shafazand S, Griffin JP, Keenan R, Bolliger CT; American College of Chest Physicians. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):161S-77S. — View Citation

Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. Epub 2007 Jun 4. — View Citation

Guntupalli KK, Reddy RM, Loutfi RH, Alapat PM, Bandi VD, Hanania NA. Evaluation of obstructive lung disease with vibration response imaging. J Asthma. 2008 Dec;45(10):923-30. doi: 10.1080/02770900802395496. — View Citation

Kramer MR, Raviv Y, Hardoff R, Shteinmatz A, Amital A, Shitrit D. Regional breath sound distribution analysis in single-lung transplant recipients. J Heart Lung Transplant. 2007 Nov;26(11):1149-54. — View Citation

Yigla M, Gat M, Meyer JJ, Friedman PJ, Maher TM, Madison JM. Vibration response imaging technology in healthy subjects. AJR Am J Roentgenol. 2008 Sep;191(3):845-52. doi: 10.2214/AJR.07.3151. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan		Prior to surgery	No
Secondary	Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative		3 months after surgery	No