Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00706485
• Collaborator: National Institutes of Health (NIH) (NIH), Implant Sciences (Other)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 33
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Neoplasms	Device: Yttrium-90 Plaque Applicator	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dural brachytherapy plaque Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.	Device: Yttrium-90 Plaque Applicator; Placed on the dura during surgery for 10-17 1/2 minutes; Other Names: Y-90 Plaque applicator

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use [At time of procedure]

Secondary Outcome Measures

1. 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]

   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.

2. Marginal Failure. [up to 10 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Thomas F. DeLaney, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tom DeLaney, MD, MD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00706485
• Other Study ID Numbers: 07-007
• First Posted: Jun 27, 2008
• Last Update Posted: Oct 19, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Tom DeLaney, MD, MD, Massachusetts General Hospital: Y-90 plaque applicator; dural brachytherapy
• Additional relevant MeSH terms: Spinal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Dural Brachytherapy Plaque
Arm/Group Description	Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dural Brachytherapy Plaque
Arm/Group Description	Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 20%
Male	4 80%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dural Brachytherapy Plaque
Arm/Group Description	Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Measure Participants	5
Number [participants]	5 100%

2. Secondary Outcome

Title	Number of Participants With Local Control
Description	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.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dural Brachytherapy Plaque
Arm/Group Description	Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Measure Participants	5
Number [participants]	5 100%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.

Arm/Group Title	Dural Brachytherapy Plaque
Arm/Group Description	Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Measure Participants	0

Adverse Events

Arm/Group Title	Dural Brachytherapy Plaque
Arm/Group Description	Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
All Cause Mortality
	Dural Brachytherapy Plaque
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Dural Brachytherapy Plaque
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Dural Brachytherapy Plaque
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.