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

NCT ID: NCT00523094

Last Updated: 2009-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Emphysema Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deep Breeze

INDUSTRY

Sponsor Role lead

Responsible Party

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Deep Breeze

Principal Investigators

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Atul C. Mehta, M.D

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 14733622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9465866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11083665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3616987 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10194239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11079482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8241207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4635418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4846113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7357934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6865454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8131537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2930068 (View on PubMed)

Other Identifiers

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DB032

Identifier Type: -

Identifier Source: org_study_id

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