Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

This study has suspended participant recruitment.
(New device for dural plaque irradiation was approved by FDA.)
Sponsor:
Collaborators:
Implant Sciences
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00706485
First received: June 25, 2008
Last updated: January 13, 2011
Last verified: January 2011
  Purpose

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 Intervention
Spinal Neoplasms
Device: Yttrium-90 Plaque Applicator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To evaluate the feasibility of titanium-enclosed and differentially-loaded Y-90 dural brachytherapy plaques in this patient population [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To optimize plaque dosimetric coverage of the target volume at risk. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine the anatomic sites of failure. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2007
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Yttrium-90 Plaque Applicator
    Placed on the dura during surgery for 10-17 1/2 minutes
    Other Name: Y-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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706485

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Implant Sciences
Investigators
Principal Investigator: Thomas F. DeLaney, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Thomas F. DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00706485     History of Changes
Other Study ID Numbers: 07-007
Study First Received: June 25, 2008
Last Updated: January 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Y-90 plaque applicator
dural brachytherapy

Additional relevant MeSH terms:
Neoplasms
Spinal Neoplasms
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on April 21, 2014