Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable

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 involve dura (the tough outer layer of the spinal cord). Tumors in the spine need a high dose of radiation to kill cancer cells. The nearby spinal cord is a sensitive area which does not safely tolerate high doses of radiation. The Y-90 plaque applicator is a special technique used to deliver the radiation dose to the tumor cells and avoid the spinal cord.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• 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

United States
Massachusetts General Hospital
Time Frame
Start Date: July 2007
Completion Date: April 2010
Target number of participants: 5
Experimental: Dural brachytherapy plaque
Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Related Therapeutic Areas
Collaborators: National Institutes of Health (NIH), Implant Sciences
Leads: Massachusetts General Hospital

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