Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT00855803
Eligibility Criteria:
Eligibility:
Inclusion:
* Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
* Patients must have a VAS of ≥4 at any of the planned treatment sites
* Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
* Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
* Narcotic pain prescription and usage information must be available and documented
* Patients must sign study specific consent
* Above the age of 18
* For women of childbearing age a negative pregnancy test is required
* Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
* Zubrod score of 0-2
Exclusion:
* Patients who have been non-ambulatory for more than 7 days
* Patients with compression fractures
* Spine instability requiring fixation
* Patients with paraspinal extension
* Patients with bony fragments
* Planned systemic treatment within one week after treatment.
* Absence of pathological diagnosis of cancer
* Chemotherapy within one week of treatment
* Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
* Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Patient had a transmural myocardial infarction within the last 6 months
* Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
* PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
* Platelet count is \< 50,000
* History of significant psychiatric illness
Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00855803
Study Brief:
Protocol Section:
NCT00855803