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

• Conditions: Lung Cancer
• Interventions: Procedure: Lung resection surgery

• Registration Number: NCT00966511
• Lead Sponsor: Deep Breeze

Brief 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.

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).

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung resection candidates	Lung resection surgery	Study participants will be patients who are candidates for lung resection (lobectomy or greater)

Primary Outcome Measures

Name	Time	Method
Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan	Prior to surgery

Secondary Outcome Measures

Name	Time	Method
Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative	3 months after surgery

Trial Locations

Locations (6)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Mt. Sinai School of Medicine; 🇺🇸 New York, New York, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Boston Medical Center, Boston University; 🇺🇸 Boston, Massachusetts, United States

New York-Presbyterian Hospital/Columbia University Medical Center; 🇺🇸 New York, New York, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States