Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Status: Recruiting
Phase: N/A
Diagnosis: Other Cancers
NCT ID: NCT00706485 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 07-007

 

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.

 

Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital

Overall PI:
Thomas DeLaney, MD, Massachusetts General Hospital

Site-responsible Investigators:
Philip Devlin, MD, Brigham and Women's Hospital

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - 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 Criteria: - 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
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