Spinal Neoplasms
Conditions
Keywords
Y-90 plaque applicator, dural brachytherapy
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).
Interventions
DEVICEYttrium-90 Plaque Applicator
Placed on the dura during surgery for 10-17 1/2 minutes
Sponsors
National Institutes of Health (NIH)
Implant Sciences
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use | At time of procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Marginal Failure. | up to 10 years | Marginal failure is defined as appearance of tumor growth at the margin of dural plaque. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Dural Brachytherapy Plaque |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use
Time frame: At time of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dural Brachytherapy Plaque | Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use | 5 participants |
Secondary
Marginal Failure.
Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.
Time frame: up to 10 years
Population: Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.
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.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dural Brachytherapy Plaque | Number of Participants With Local Control | 5 participants |