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

Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Cancer, Metastasis, Pain

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Trial Information

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


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

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

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

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

- Karnofsky Performance status >40

- Expected life expectancy of 6 months or greater, as estimated by the physician in

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the effect of intravertebral injection of Samarium on the relief of pain

Principal Investigator

Hani Ashamalla, MD, FCCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Methodist Hospital


United States: Institutional Review Board

Study ID:




Start Date:

May 2006

Completion Date:

August 2006

Related Keywords:

  • Cancer
  • Metastasis
  • Pain
  • 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
  • Neoplasm Metastasis
  • Neoplasms, Second Primary



New York Methodist Hospital Brooklyn, New York  11215-3609