Trial Information

Phase I/II Study of the Use of Vertebral Intracavitary Cement and Samarium (VICS) for Painful Vertebral Metastases

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)