Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

NCT00523094 | Suspended

• 1 other identifier: DB032
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Emphysema; Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients evaluated for lung surgery who will undergo perfusion scan

You may qualify if:

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

You may not qualify if:

• Chest wall deformation;
• Spine deformation (including scoliosis);
• Hirsutism;
• Potentially contagious skin lesion on the back;
• Skin lesion that would interfere with sensor placement; (Keloids)
• Cardiac pacemaker or implantable defibrillator;

Sponsors & Collaborators

• Deep Breeze: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (13)

• Benditt JO. Surgical therapies for chronic obstructive pulmonary disease. Respir Care. 2004 Jan;49(1):53-61; discussion 61-3.

  PMID: 14733622 BACKGROUND

• Gurney JW. Pathophysiology of obstructive airways disease. Radiol Clin North Am. 1998 Jan;36(1):15-27. doi: 10.1016/s0033-8389(05)70005-1.

  PMID: 9465866 BACKGROUND

• Salzman SH. Can CT measurement of emphysema severity aid patient selection for lung volume reduction surgery? Chest. 2000 Nov;118(5):1231-2. doi: 10.1378/chest.118.5.1231. No abstract available.

  PMID: 11083665 BACKGROUND

• Corris PA, Ellis DA, Hawkins T, Gibson GJ. Use of radionuclide scanning in the preoperative estimation of pulmonary function after pneumonectomy. Thorax. 1987 Apr;42(4):285-91. doi: 10.1136/thx.42.4.285.

  PMID: 3616987 BACKGROUND

• Arcasoy SM, Kotloff RM. Lung transplantation. N Engl J Med. 1999 Apr 8;340(14):1081-91. doi: 10.1056/NEJM199904083401406. No abstract available.

  PMID: 10194239 BACKGROUND

• Hardoff R, Steinmetz AP, Krausz Y, Bar-Sever Z, Liani M, Kramer MR. The prognostic value of perfusion lung scintigraphy in patients who underwent single-lung transplantation for emphysema and pulmonary fibrosis. J Nucl Med. 2000 Nov;41(11):1771-6.

  PMID: 11079482 BACKGROUND

• Cooper JD, Billingham M, Egan T, Hertz MI, Higenbottam T, Lynch J, Mauer J, Paradis I, Patterson GA, Smith C, et al. A working formulation for the standardization of nomenclature and for clinical staging of chronic dysfunction in lung allografts. International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 1993 Sep-Oct;12(5):713-6.

  PMID: 8241207 BACKGROUND

• Kristersson S, Lindell SE, Svanberg L. Prediction of pulmonary function loss due to pneumonectomy using 133 Xe-radiospirometry. Chest. 1972 Dec;62(6):694-8. doi: 10.1378/chest.62.6.694. No abstract available.

  PMID: 4635418 BACKGROUND

• Olsen GN, Block AJ, Tobias JA. Prediction of postpneumonectomy pulmonary function using quantitative macroaggregate lung scanning. Chest. 1974 Jul;66(1):13-6. doi: 10.1378/chest.66.1.13. No abstract available.

  PMID: 4846113 BACKGROUND

• Ali MK, Mountain CF, Ewer MS, Johnston D, Haynie TP. Predicting loss of pulmonary function after pulmonary resection for bronchogenic carcinoma. Chest. 1980 Mar;77(3):337-42. doi: 10.1378/chest.77.3.337.

  PMID: 7357934 BACKGROUND

• Ali MK, Ewer MS, Atallah MR, Mountain CF, Dixon CL, Johnston DA, Haynie TP. Regional and overall pulmonary function changes in lung cancer. Correlations with tumor stage, extent of pulmonary resection, and patient survival. J Thorac Cardiovasc Surg. 1983 Jul;86(1):1-8.

  PMID: 6865454 BACKGROUND

• Kearney DJ, Lee TH, Reilly JJ, DeCamp MM, Sugarbaker DJ. Assessment of operative risk in patients undergoing lung resection. Importance of predicted pulmonary function. Chest. 1994 Mar;105(3):753-9. doi: 10.1378/chest.105.3.753.

  PMID: 8131537 BACKGROUND

• Markos J, Mullan BP, Hillman DR, Musk AW, Antico VF, Lovegrove FT, Carter MJ, Finucane KE. Preoperative assessment as a predictor of mortality and morbidity after lung resection. Am Rev Respir Dis. 1989 Apr;139(4):902-10. doi: 10.1164/ajrccm/139.4.902.

  PMID: 2930068 BACKGROUND

MeSH Terms

Conditions

Emphysema; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atul C. Mehta, M.D

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 30, 2007
• Study Start: September 1, 2007
• Study Completion: July 1, 2008
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

US (1)