Effect of Samarium on the Relief of Pain Due to Vertebral Metastases (NCT00374751) | Clinical Trial Compass
CompletedPhase 1/2
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
United States29 participantsStarted 2006-05
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
What they're measuring
1
To determine the effect of intravertebral injection of Samarium on the relief of pain
Timeframe: 6 months
Trial details
NCT IDNCT00374751
SponsorNew York Presbyterian Brooklyn Methodist Hospital