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New device for dural plaque irradiation was approved by FDA.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Implant Sciences | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dural brachytherapy plaque | Experimental | Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium-90 Plaque Applicator | Device | Placed on the dura during surgery for 10-17 1/2 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use | At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas F. DeLaney, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dural Brachytherapy Plaque | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dural Brachytherapy Plaque | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use | Posted | Number | participants | At time of procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dural Brachytherapy Plaque | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas F. DeLaney, M.D. | Massachusetts General Hospital | 617-726-6876 | tdelaney@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D013125 | Spinal Neoplasms |
| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
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| Marginal Failure. | Marginal failure is defined as appearance of tumor growth at the margin of dural plaque. | up to 10 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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. | Posted | Number | participants | at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10 |
|
|
|
| Secondary | Marginal Failure. | Marginal failure is defined as appearance of tumor growth at the margin of dural plaque. | Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome. | Posted | up to 10 years |
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| 0 |
| 5 |
| 0 |
| 5 |
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| D009140 |
| Musculoskeletal Diseases |
| D013122 | Spinal Diseases |