Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
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|ClinicalTrials.gov Identifier: NCT00706485|
Recruitment Status : Terminated (New device for dural plaque irradiation was approved by FDA.)
First Posted : June 27, 2008
Results First Posted : October 19, 2016
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Spinal Neoplasms||Device: Yttrium-90 Plaque Applicator||Not Applicable|
- The surgeon will remove the participants tumor from the outer layer of the spinal cord (dura). The Y-90 applicator and a "dummy" applicator will be brought to the surgery table in a protected container. A "dummy" applicator is the same size and shape as the Y-90 plaque applicator but does not contain radioactive plaque. The "dummy" applicator will be placed on the participants dura to make sure it fits properly, then it will be removed. The working Y-90 applicator will be placed on the dura for 10-17 1/2 minutes and then be removed.
- External beam irradiation is a type of high-energy radiation used to kill cancer cells and shrink tumors. This radiation will be given to the participant only if they have not had it prior to the study.
- After the treatment, participants will be asked to return for a follow-up visit 6 weeks, 3 months, every 6 months thereafter for 4 years, then annually to year 10. At these visits, they will have the following: physical examination; recent medical history; MRI or CT scan (twice each year) and; chest x-ray or chest CT (twice each year).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Dural brachytherapy plaque
Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Device: Yttrium-90 Plaque Applicator
Placed on the dura during surgery for 10-17 1/2 minutes
Other Name: Y-90 Plaque applicator
- Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use [ Time Frame: At time of procedure ]
- 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 ]Local failure is defined as: extension of the tumor margin[s] in any direction at least 5 mm beyond that present on the pre-treatment imaging studies or the appearance of -tumor in tissues previously scored as sites of sub-clinical disease. Local control is absence of local failure.
- Marginal Failure. [ Time Frame: up to 10 years ]Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706485
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Thomas F. DeLaney, MD||Massachusetts General Hospital|