Neoplasms

Musculoskeletal Diseases

All Conditions

Spinal Neoplasms

Bone Neoplasms

Bone Diseases

Spinal Diseases

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Placed on the dura during surgery for 10-17 1/2 minutes

Yttrium-90 Plaque Applicator

Thomas F. DeLaney, MD

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.

* 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).

Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

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 is defined as appearance of tumor growth at the margin of dural plaque.

National Institutes of Health (NIH)

Implant Sciences

Massachusetts General Hospital

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes

Dural Brachytherapy Plaque

Age, Categorical

Sex: Female, Male

Thomas F. DeLaney, M.D.

Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use

Number of Participants With Local Control

Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators	NCT00706485	Spinal Neoplasm...	Yttrium-90 Plaq...	18 Years -	Massachusetts General Hospital
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators	NCT00706485	Spinal Neoplasm...	Yttrium-90 Plaq...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for dural brachytherapy