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Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016938
First Posted: November 20, 2009
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
Results First Submitted: December 2, 2015  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Lung Cancer

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dynamic Lung MRI Lung Tumor Motion and Function

Participant Flow:   Overall Study
    Dynamic Lung MRI
STARTED   16 
COMPLETED   7 
NOT COMPLETED   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dynmaic Lung MRI Lung Tumor Motion and Function

Baseline Measures
   Dynmaic Lung MRI 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   11 
Gender 
[Units: Participants]
 
Female   4 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors   [ Time Frame: 2 years ]

2.  Secondary:   Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Warren D'Souza, PhD, MBA
Organization: Universtity of Maryland School of Medicine
phone: 410-328-7159
e-mail: wdsouza@umm.edu



Responsible Party: Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier: NCT01016938     History of Changes
Other Study ID Numbers: HP-00043875
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: December 2, 2015
Results First Posted: May 18, 2016
Last Update Posted: May 18, 2016