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

NCT00966511 | Unknown DMC

• 1 other identifier: DB041
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Lung Cancer

Keywords

lung cancer; lung resection; lobectomy; pneumonectomy; lung function; perfusion

Outcome Measures

Primary Outcomes (1)

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

  Prior to surgery

Secondary Outcomes (1)

• Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative

  3 months after surgery

Study Arms (1)

Lung resection candidates

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

Procedure: Lung resection surgery

Interventions

Lung resection surgery PROCEDURE

The study is designed in a way that will not alter the surgeon's decision based on routine assessment of candidates for resection (lobectomy or greater). Namely, the VRI data will be gathered prospectively; however, the analyses using VRI data will be performed retrospectively.

Lung resection candidates

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Deep Breeze: lead

Study Sites (6)

Yale University School of Medicine

New Haven, Connecticut, 06520-8062, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Boston Medical Center, Boston University

Boston, Massachusetts, 02118, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (6)

• Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.

  PMID: 17551264 BACKGROUND

• Kramer MR, Raviv Y, Hardoff R, Shteinmatz A, Amital A, Shitrit D. Regional breath sound distribution analysis in single-lung transplant recipients. J Heart Lung Transplant. 2007 Nov;26(11):1149-54. doi: 10.1016/j.healun.2007.07.039.

  PMID: 18022081 BACKGROUND

• Yigla M, Gat M, Meyer JJ, Friedman PJ, Maher TM, Madison JM. Vibration response imaging technology in healthy subjects. AJR Am J Roentgenol. 2008 Sep;191(3):845-52. doi: 10.2214/AJR.07.3151.

  PMID: 18716118 BACKGROUND

• Guntupalli KK, Reddy RM, Loutfi RH, Alapat PM, Bandi VD, Hanania NA. Evaluation of obstructive lung disease with vibration response imaging. J Asthma. 2008 Dec;45(10):923-30. doi: 10.1080/02770900802395496.

  PMID: 19085584 BACKGROUND

• Becker HD, Slawik M, Miyazawa T, Gat M. Vibration response imaging as a new tool for interventional-bronchoscopy outcome assessment: a prospective pilot study. Respiration. 2009;77(2):179-94. doi: 10.1159/000182972. Epub 2008 Dec 9.

  PMID: 19065052 BACKGROUND

• Colice GL, Shafazand S, Griffin JP, Keenan R, Bolliger CT; American College of Chest Physicians. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):161S-77S. doi: 10.1378/chest.07-1359.

  PMID: 17873167 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Frank C Detterbeck, MD

  Yale University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 9, 2011

Record last verified: 2011-02

Locations

US (6)