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Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

This study has been terminated.
(New device for dural plaque irradiation was approved by FDA.)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Implant Sciences
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00706485
First received: June 25, 2008
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: October 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Spinal Neoplasms
Intervention: Device: Yttrium-90 Plaque Applicator

  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
Dural Brachytherapy Plaque

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes


Participant Flow:   Overall Study
    Dural Brachytherapy Plaque
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 



  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
Dural Brachytherapy Plaque

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes


Baseline Measures
   Dural Brachytherapy Plaque 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   1 
Male   4 


  Outcome Measures
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1.  Primary:   Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use   [ Time Frame: At time of procedure ]

2.  Secondary:   Number of Participants With Local Control   [ Time Frame: at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10 ]

3.  Secondary:   Marginal Failure.   [ Time Frame: up to 10 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: Thomas F. DeLaney, M.D.
Organization: Massachusetts General Hospital
phone: 617-726-6876
e-mail: tdelaney@mgh.harvard.edu



Responsible Party: Tom DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00706485     History of Changes
Other Study ID Numbers: 07-007
Study First Received: June 25, 2008
Results First Received: October 18, 2016
Last Updated: October 18, 2016