Clinical trial · Interventional
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
Phase I/II Study of the Use of Vertebral Intracavitary Cement and Samarium (VICS) for Painful Vertebral Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastasis | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Samarium (153SM) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Samarium (153SM)
- description
- Injection of Samarium (153SM)
- interventionNames
- Drug: Samarium (153SM)
Primary outcomes (1)
- measure
- To determine the effect of intravertebral injection of Samarium on the relief of pain
- timeFrame
- 6 months
- description
- Measuring the pain by the Visual Analogue Scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available