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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00374751
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00374751
Study Brief:
Protocol Section:
NCT00374751