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

Completed · Phase 1/Phase 2

Conditions studied: Cancer, Metastasis, Pain

In brief

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.

Key facts

Study ID

NCT00374751

Run by

New York Presbyterian Brooklyn Methodist Hospital

People needed

29

Starts

2006-05-01

Expected to finish

2016-01-01

Last updated by the study team

2019-08-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York Methodist Hospital — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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