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

Deep Breeze

Status: Unknown

Conditions: Lung Cancer

Treatments: Procedure: Lung resection surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT00966511

DB041

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Lung resection candidates

Description:

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

Treatment:

Procedure: Lung resection surgery