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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by New York Methodist Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
New York Methodist Hospital
ClinicalTrials.gov Identifier:
NCT00374751
First received: September 8, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.

We are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.


Condition Intervention Phase
Cancer
Metastasis
Pain
Drug: Samarium (153SM)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of the Use of Vertebral Intracavitary Cement and Samarium (VICS) for Painful Vertebral Metastases

Resource links provided by NLM:


Further study details as provided by New York Methodist Hospital:

Primary Outcome Measures:
  • To determine the effect of intravertebral injection of Samarium on the relief of pain

Secondary Outcome Measures:
  • To evaluate the effect of this procedure on the size of the vertebral metastatic deposits

Estimated Enrollment: 30
Study Start Date: May 2006
Estimated Study Completion Date: August 2006
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)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374751

Contacts
Contact: Adel Guirguis, MD, Ms (718) 780-3677 adg9003@nyp.org

Locations
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Principal Investigator: Hani Ashamalla, MD, FCCP         
Sponsors and Collaborators
New York Methodist Hospital
Investigators
Principal Investigator: Hani Ashamalla, MD, FCCP New York Methodist Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374751     History of Changes
Other Study ID Numbers: NYM-354
Study First Received: September 8, 2006
Last Updated: September 8, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by New York Methodist Hospital:
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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014