Status:
TERMINATED
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Implant Sciences
Conditions:
Spinal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to determine the feasibility of the Y-90 plaque applicator. The Y-90 plaque application is designed to deliver high doses of radiation to tumors in the spine that...
Detailed Description
* 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 contai...
Eligibility Criteria
Inclusion
- Pathological diagnosis of malignant tumor involving spine with extraosseous extension or arising in paraspinal soft tissues with tumor involving or abutting the dura. Patients with a limited metastatic disease and tumor involving the spine or paraspinal soft tissues and who are judged to benefit from surgery will also be eligible.
- Lesion may be primary or recurrent after prior surgery
- No clinical, radiographic or other evidence of distant metastatic tumor
- Fit for receiving the planned radiation dose to the affected site. No known genetic disease or medical condition associated with an abnormal radiation sensitivity.
- 18 years of age or older
- KPS of 70 or greater (excluding consideration of poor function due to the local growth or systemic metabolic effects of the tumor
Exclusion
- Disease/conditions characterized by high radiation sensitivity
- Pregnancy
- Evidence of cord/cauda malfunction for causes other than effect os local tumor growth or due to metabolic effects of tumor
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00706485
Start Date
July 1 2007
End Date
April 1 2010
Last Update
October 19 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115