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Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

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ClinicalTrials.gov Identifier: NCT00706485
Recruitment Status : Terminated (New device for dural plaque irradiation was approved by FDA.)
First Posted : June 27, 2008
Results First Posted : October 19, 2016
Last Update Posted : October 19, 2016
National Institutes of Health (NIH)
Implant Sciences
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Neoplasms Device: Yttrium-90 Plaque Applicator Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
Study Start Date : July 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

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 Name: Y-90 Plaque applicator

Primary Outcome Measures :
  1. Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use [ Time Frame: At time of procedure ]

Secondary Outcome Measures :
  1. Number of Participants With Local Control [ Time Frame: at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10 ]
    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.

  2. Marginal Failure. [ Time Frame: up to 10 years ]
    Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706485

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Implant Sciences
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Principal Investigator: Thomas F. DeLaney, MD Massachusetts General Hospital
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Responsible Party: Tom DeLaney, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00706485    
Other Study ID Numbers: 07-007
First Posted: June 27, 2008    Key Record Dates
Results First Posted: October 19, 2016
Last Update Posted: October 19, 2016
Last Verified: October 2016
Keywords provided by Tom DeLaney, MD, Massachusetts General Hospital:
Y-90 plaque applicator
dural brachytherapy
Additional relevant MeSH terms:
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Spinal Neoplasms
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases