Status:
UNKNOWN
Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
Lead Sponsor:
Deep Breeze
Conditions:
Lung Cancer
Eligibility:
All Genders
18-90 years
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 contributio...
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 wi...
Eligibility Criteria
Inclusion
- Able and willing to read, understand, and provide written Informed Consent;
- Age range of 18-90 years;
- 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.
- BMI \> 19.
Exclusion
- 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);
- There should be no active pulmonary infection (e.g. pneumonia) at the time of the recordings;
- Hirsutism unless patient is willing to have back shaved;
- Potentially contagious skin lesion on the back;
- Giant bulla (more than 1/3 of the hemithorax or \>10cm)
- Pregnant women
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00966511
Start Date
June 1 2009
End Date
December 1 2011
Last Update
February 9 2011
Active Locations (6)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8062
2
Emory University
Atlanta, Georgia, United States, 30322
3
Boston Medical Center, Boston University
Boston, Massachusetts, United States, 02118
4
Mt. Sinai School of Medicine
New York, New York, United States, 10029