Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Mass General Brigham

Status: Terminated

Conditions: Spinal Neoplasms

Treatments: Device: Yttrium-90 Plaque Applicator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00706485

07-007

Details and patient eligibility

About

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.

Full 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 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).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Dural brachytherapy plaque

Experimental group

Description:

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Treatment:

Device: Yttrium-90 Plaque Applicator