Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Spinal Neoplasms Clinical Trial

Official title:

Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00706485
• Other study ID #: 07-007
• Status: Terminated
• Phase: N/A
• First received: June 25, 2008
• Last updated: October 18, 2016
• Start date: July 2007
• Est. completion date: April 2010

Study information

• Verified date: October 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Neoplasms

Intervention

Device:
• Yttrium-90 Plaque Applicator
Placed on the dura during surgery for 10-17 1/2 minutes

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Implant Sciences, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use		At time of procedure	Yes
Secondary	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	No
Secondary	Marginal Failure.	Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.	up to 10 years	No