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Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Primary Purpose

Spinal Neoplasms

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Yttrium-90 Plaque Applicator

About this trial

This is an interventional treatment trial for Spinal Neoplasms focused on measuring Y-90 plaque applicator, dural brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dural brachytherapy plaque

Arm Description

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Marginal Failure.

Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.

Full Information

NCT ID

NCT00706485

First Posted

June 25, 2008

Last Updated

October 18, 2016

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH), Implant Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00706485

Brief Title

Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Official Title

Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Why Stopped

New device for dural plaque irradiation was approved by FDA.

Study Start Date

July 2007 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH), Implant Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Neoplasms

Keywords

Y-90 plaque applicator, dural brachytherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dural brachytherapy plaque

Arm Type

Experimental

Arm Description

Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.

Intervention Type

Device

Intervention Name(s)

Yttrium-90 Plaque Applicator

Other Intervention Name(s)

Y-90 Plaque applicator

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Number of Participants With Local Control

Description

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

Title

Marginal Failure.

Description

Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.

Time Frame

up to 10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas F. DeLaney, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

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Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

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