Clinical trial NCT00523094: Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure
Official title: Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Emphysema
Cancer
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2007-08-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients evaluated for lung surgery who will undergo perfusion scan

Brief summary: The primary objective of this study is to estimate the accuracy of the pre-operative VRI quantitative results versus the gold standard pre-operative perfusion scan.

The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second \[FEV1\] and diffusing capacity of the lung for carbon monoxide \[DLCO\]) in patients who underwent surgical resection.

Detailed description: Pre lung operation candidates for procedures such as lung volume reduction surgery (LVRS), lung resection, bullectomy and lung transplant are frequently evaluated for differential lung function by a semi quantitative lung scintigraphy. VRI may offer the same differential lung function information for the physician without the risks, time and patient discomfort of lung scintigraphy in the treating physician office.

Moreover, VRI may provide a safe, quick and simple method to measure "split function" in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion "split function" methods.

In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.

Eligibility criteria: Inclusion Criteria:

1. Able and willing to read, understand, and provide written informed consent;
2. Male or female in the age range of 18-80 years;
3. Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy.
4. Body mass index (BMI) \> 21.

Exclusion Criteria:

1. Chest wall deformation;
2. Spine deformation (including scoliosis);
3. Hirsutism;
4. Potentially contagious skin lesion on the back;
5. Skin lesion that would interfere with sensor placement; (Keloids)
6. Cardiac pacemaker or implantable defibrillator;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Atul C. Mehta, M.D
role: PRINCIPAL_INVESTIGATOR
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