Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
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.
Protocol:

 1. Patients with bone metastases will be identified and discussed in the weekly joint
 Neuroscience meeting held in Radiation Oncology Department.

 2. If the patient is eligible to this study, the protocol will be offered to him/her. If
 the patient accepts; informed consent will be obtained.

 3. The case will be scheduled jointly by Neurosurgeon and Radiation Oncologist.

 4. Radiation physicist orders the radioactive samarium.

 During the procedure:

 1. Neurosurgical procedure ( kyphoplasty/vertebroplasty) is performed as standard using .
 mild general sedation and local anesthesia.

 2. Once a cavity is identified in fluoroscopy, the trocar is secured. The volume and
 pressure of the kyphoplasty balloon are recorded.

 3. According to standard practice; only the radiation team (Radiation oncologist,
 Physicist) is handling the radioactive material. All work is done under sterile
 conditions.

 4. Two mCi. of Samarium is prepared after serial dilution steps under radiation precautions
 in the department of radiation oncology and material is transferred to OR.

 5. 0.5ml of "Head Cement" is administered first to act as a seal.

 6. The Samarium is then introduced into the vertebral cavity using a 2-way valve by the
 Radiation Oncologist. Total of 0.5ml (Samarium+0.2ml radio opaque material)

 7. The "Foot cement" (0.5 ml) is then introduced via the same 2-way valve into the
 vertebral cavity by the neurosurgeon to flush any remains of radioactivity in the
 system.

 8. The two way valve is then removed and the rest of kyphoplasty/vertebroplasty is ensued
 as per their ordinary protocol.

 9. Final volume of cement injected is recorded.

 10. After securing the wound, all devices, syringes, gloves and basins used for handling the
 radioactive substance are collected in a "red bag" and stored by radiation safety
 officer in the hot lab. till full radioactive decay.

 11. The room is scanned after patient's discharge, any spillage should be reported to
 radiation safety officer and normal procedures for environmental protection are ensued.

 Post Procedure:

 1. Normal neurosurgical recovery room protocol is employed. No radiation precautions
 needed.

 2. Patient can be discharged home. No delays because of radiation precautions

 3. Once patient is cleared, a nuclear imaging scan is obtained with Gamma camera. The ratio
 of uptake in the vertebra to background is calculated. Moreover, Full body scan is
 obtained to identify other areas of uptake if any.

 4. A second nuclear imaging scan is done on the 4th day of the procedure (Two half Lives)
 to document significant decay and calculate dose.

 5. MRI/CT scan of the area treated should be done in 4 weeks to assess outcome.

 6. Clinical follow up is obtained at 2, 4 weeks and in 3 months. Careful pain score
 assessment is included in each time (Use Study Flow Sheet)
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