Malignant vertebral bone tumor.
Conditions
Interventions
Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the vertebral body involved by malignant tumor and cement is injected.
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Primary or metastatic malignant tumor in thoracic or lumber vertebral bone. 2) Severe pain adversely influencing on QOL. 3) No involvement into the spinal canal. 4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 6) Expected survival more than 4 weeks. 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Bleeding time more than 5 minutes. 2) Fever above 38 degrees Celsius. 3) Cardiac failure requiring medication. 4) Active inflammation in vertebrae 5) Severely collapsed vertebrae (less than one third of normal height). 6) No severe pain (less than 2 of VAS). 7) Unable to keep prone position for 1 hour. 8) Necessity of procedure for more than 5 contiguous vertebral bodies. 9) Necessity of single session procedure for more than 4 vertebral bodies. 10) Severe drug allergy. 11) Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain evaluated by Visual Analogue Scale (VAS). | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed