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


N/A
18 Years
90 Years
Open (Enrolling by invite only)
Both
Lung Cancer

Thank you

Trial Information

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


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).


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan

Outcome Time Frame:

Prior to surgery

Safety Issue:

No

Principal Investigator

Frank C Detterbeck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University Medical School

Authority:

United States: Institutional Review Board

Study ID:

DB041

NCT ID:

NCT00966511

Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Lung Cancer
  • lung cancer
  • lung resection
  • lobectomy
  • pneumonectomy
  • lung function
  • perfusion
  • Lung Neoplasms

Name

Location
Emory University Atlanta, Georgia  30322
Yale University School Of Medicine New Haven, Connecticut  06520
Mt. Sinai School of Medicine New York, New York  10029
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
Boston Medical Center, Boston University Boston, Massachusetts  02118
New York-Presbyterian Hospital/Columbia University Medical Center New York, New York  10032