Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

NCT00706485 | Terminated Results DMC

• 1 other identifier: 07-007
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Neoplasms

Keywords

Y-90 plaque applicator; dural brachytherapy

Outcome Measures

Primary Outcomes (1)

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

  At time of procedure

Secondary Outcomes (2)

• Number of Participants With Local Control

  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.

  up to 10 years

Study Arms (1)

Dural brachytherapy plaque

EXPERIMENTAL

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Device: Yttrium-90 Plaque Applicator

Interventions

Yttrium-90 Plaque Applicator DEVICE

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

Also known as: Y-90 Plaque applicator

Dural brachytherapy plaque

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• Implant Sciences: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Spinal Neoplasms

Condition Hierarchy (Ancestors)

Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Results Point of Contact

• Title: Thomas F. DeLaney, M.D.
• Organization: Massachusetts General Hospital

tdelaney@mgh.harvard.edu

617-726-6876

Study Officials

• Thomas F. DeLaney, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: July 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 19, 2016
• Results First Posted: October 19, 2016

Record last verified: 2016-10

Locations

US (1)