An interventional study of Yttrium-90 Plaque Applicator in Spinal Neoplasms, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-19.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
18 studies on the registry are indexed under Spinal Neoplasms; 5 are open to participants now.
This study's enrollment of 5 is below the median of 71 across 11 interventional studies indexed under Spinal Neoplasms.
Browse Spinal Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Y-90 Plaque applicator
Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use
Time frame: At time of procedure
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
Marginal Failure.
Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.
Time frame: up to 10 years
| Milestone | Dural Brachytherapy Plaque |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| participants | Dural Brachytherapy Plaque |
|---|---|
| Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use | 5 |
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.
| participants | Dural Brachytherapy Plaque |
|---|---|
| Number of Participants With Local Control | 5 |
Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dural Brachytherapy Plaque | — | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Dural Brachytherapy Plaque |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Dural Brachytherapy Plaque |
|---|---|
| Female | 1 |
| Male | 4 |
The record gives a start of Jul 2007, a primary completion of Apr 2010 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2016, 6 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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