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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00523094
• Other study ID #: DB032
• Status: Suspended
• Phase: N/A
• First received: August 29, 2007
• Last updated: June 15, 2009
• Start date: September 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2009
• Source: Deep Breeze
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 75
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Emphysema

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Country where clinical trial is conducted

United States, 

References & Publications (13)

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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. — View Citation

Arcasoy SM, Kotloff RM. Lung transplantation. N Engl J Med. 1999 Apr 8;340(14):1081-91. Review. — View Citation

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

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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. — View Citation

Gurney JW. Pathophysiology of obstructive airways disease. Radiol Clin North Am. 1998 Jan;36(1):15-27. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Olsen GN, Block AJ, Tobias JA. Prediction of postpneumonectomy pulmonary function using quantitative macroaggregate lung scanning. Chest. 1974 Jul;66(1):13-6. — View Citation

Salzman SH. Can CT measurement of emphysema severity aid patient selection for lung volume reduction surgery? Chest. 2000 Nov;118(5):1231-2. — View Citation

* Note: There are 13 references in all — Click here to view all references