Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
Condition: Cancer; Metastasis; Pain
MeSH terms: Neoplasm Metastasis; Neoplasms, Second Primary
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      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)
    

Intervention name(s): Samarium (153SM)
Intervention type(s): Drug
Intervention description(s): The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Samarium; Kyphoplasty; Pain management; Bone metastases; Histologically proven malignancy in the primary site; Radiographic evidence of bone metastasis; Significant pain equal or more than score 5; Karnofsky Performance status >40; The patient must sign a study specific informed consent