Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
18 Years
N/A
Both
Spinal Neoplasms
Trial Information
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
- 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).
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the feasibility of titanium-enclosed and differentially-loaded Y-90 dural brachytherapy plaques in this patient population
Outcome Time Frame:
10 years
Safety Issue:
Yes
Principal Investigator
Thomas F. DeLaney, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
07-007
NCT ID:
NCT00706485
Start Date:
July 2007
Completion Date:
July 2017
Related Keywords:
- Spinal Neoplasms
- Y-90 plaque applicator
- dural brachytherapy
- Neoplasms
- Spinal Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
