Vibration Response Imaging (VRI) in Lung Cancer Patients
1 other identifier
observational
100
1 country
1
Brief Summary
Primary Objective:
- To estimate the accuracy of the pre-operative VRI QRF (Quantitative Regional Function) results versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion) pre-operative scan. Secondary Objective:
- 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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 24, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 1, 2012
July 1, 2012
2.8 years
July 24, 2007
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To learn the level of accuracy of pre-surgery results from the Vibration Response Imaging (VRI) system compared with the results from the standard pre-surgery lung function test that is performed on patients with lung cancer or cancer in the chest.
4 Years
Secondary Outcomes (1)
To learn the level of accuracy of the VRI system in predicting how the lungs will function after surgery.
4 Years
Study Arms (1)
VRI System
Vibration Response Imaging (VRI) System
Interventions
Lung function test performed using the VRI system immediately before or after the standard lung function test.
Eligibility Criteria
Patients diagnosed with lung cancer or other intrathoracic malignancy.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Deep Breezecollaborator
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodolfo C. Morice, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2007
First Posted
July 25, 2007
Study Start
November 1, 2006
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 1, 2012
Record last verified: 2012-07