Vibration Response Imaging (VRI) in the Preoperative Management in Patients With Non-Small Cell Lung Cancer

NCT00845143 | Unknown

• 1 other identifier: 003 HD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (FEV1 and DLCO) in patients who underwent surgical resection (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion capacity for carbon monoxide. ppo = predicted postoperative.)and versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion)

Conditions

Non-Small Cell Lung Cancer; Lung Function

Keywords

Non-small cell lung cancer; surgery; lung function

Outcome Measures

Primary Outcomes (1)

• lung function testing diffusion capacity VRI

  pre- 6 weeks post and 3 month postoperative

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with operable non-small cell lung cancer

You may qualify if:

• Able and willing to read, understand, and provide written Informed Consent, and
• Male or Female in the age range 18-90 years, and
• Referred to perform QRRVP test for pre lung surgery evaluation due to lung cancer or other intrathoracic malignancy, and
• BMI (body mass index) equal to or greater than 19

You may not qualify if:

• Chest wall deformation, or
• Spine deformation (including severe scoliosis), or
• Hirsutism on back, or
• Potentially contagious skin lesion on the back, or
• Skin lesion that would interfere with sensor placement, or
• Cardiac pacemaker or implantable defibrillator
• Pregnancy (all women of childbearing age must have a negative pregnancy test before beginning the study) or breast feeding

Sponsors & Collaborators

• Heidelberg University: lead

Related Publications (4)

• 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

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

  PMID: 14733622 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

• 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 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 18, 2009

Record last verified: 2009-02