Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Neoplasms
• Intervention / Treatment: Device: Yttrium-90 Plaque Applicator

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 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).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dural brachytherapy plaque; Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.	Device: Yttrium-90 Plaque Applicator; Placed on the dura during surgery for 10-17 1/2 minutes; Other Names: Y-90 Plaque applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use	At time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Local Control	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.	at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10
Marginal Failure.	Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.	up to 10 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institutes of Health (NIH); Implant Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 25, 2008
• First Submitted That Met QC Criteria: June 25, 2008
• First Posted (Estimate): June 27, 2008

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Y-90 plaque applicator; dural brachytherapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Bone Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: 07-007