Overview

Effect of Samarium on the Relief of Pain Due to Vertebral Metastases

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
Summary
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance. The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York Methodist Hospital
New York Presbyterian Brooklyn Methodist Hospital
Criteria
Inclusion Criteria:

- The patient must be 18 years of age or older

- The patient must have histologically proven malignancy in the primary site (breast,
prostate, or lung)

- The patient must have a radiographic evidence of bone metastasis, and this must have
been performed within 8 weeks prior to enrollment in the study. Acceptable studies
include plain radiographs, radionuclide bone scans, computed tomography scans,
magnetic resonance imaging, and PET-CT scans.

- The patient must have an intact anterior wall of spinal canal

- The patient must have significant pain (score 6 or above,)which appears to be related
to the radiographically documented metastatic vertebra(e) in concern, as measured by
the "Visual Analog Scale"

- The patient must be surgically and medically accepted for vertebroplasty/kyphoplasty
operation

- Karnofsky Performance status >40

- Expected life expectancy of 6 months or greater, as estimated by the physician in
charge.

- The patient must sign a study specific informed consent prior to enrollment

Exclusion Criteria:

- Epidural soft tissue component

- Patients with vertebral metastases and with clinical or radiographic evidence of
spinal cord or cauda equina impingement (effacement) or compression

- Inability to undergo anesthesia

- Hematologic primary malignancies Patients received systemic radiotherapy (89SR or
153SM)within 30 days prior to enrollmen