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Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

This study has been terminated.
(New device for dural plaque irradiation was approved by FDA.)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Implant Sciences
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00706485
First received: June 25, 2008
Last updated: October 18, 2016
Last verified: October 2016

June 25, 2008
October 18, 2016
July 2007
April 2010   (final data collection date for primary outcome measure)
Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use [ Time Frame: At time of procedure ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00706485 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.
  • 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 ]
Not Provided
Not Provided
 
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
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.
  • 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).
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Neoplasms
Device: Yttrium-90 Plaque Applicator
Placed on the dura during surgery for 10-17 1/2 minutes
Other Name: Y-90 Plaque applicator
Experimental: Dural brachytherapy plaque
Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Intervention: Device: Yttrium-90 Plaque Applicator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00706485
07-007
Yes
Not Provided
Not Provided
Tom DeLaney, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • National Institutes of Health (NIH)
  • Implant Sciences
Principal Investigator: Thomas F. DeLaney, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP