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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT01231061
Eligibility Criteria:
Inclusion Criteria:
1. The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study (bone scan, PET, CT, or MRI). A solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. A paraspinal mass ≤ 5 cm is allowed.
2. Zubrod Performance Status 0-2;
3. Age ≥ 18;
4. History/physical examination within 2 weeks prior to registration;
5. No pregnancy for women of childbearing potential;
6. MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement. MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component. If possible, an MRI with thin slice thickness (\<1mm) with 3D reconstruction quality would be most preferable for treatment planning purpose.
7. Numerical Rating Pain Scale within 1 week prior to registration. The patient must have a score on the Scale of ≥ 4 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible.
8. Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; see Appendix IV for the standardized neurological examination. Patients with mild to moderate neurological signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
9. Patients with epidural compression are eligible provided that there is no significant displacement or compression on the spinal cord itself.
10. Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible.
11. Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
1. Histologies of myeloma or lymphoma.
2. Patients with any spine metastasis with a rating of \< 4 on the Numerical Rating Pain Scale.
3. Non-ambulatory patients.
4. Spine instability due to a compression fracture.
5. \> 50% loss of vertebral body height.
6. Significant spinal cord compression or displacement.
7. Patients with rapid neurologic decline.
8. Bony retropulsion causing neurologic abnormality.
9. Prior radiation to the index spine.
10. Patients for whom an MRI of the spine is medically contraindicated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01231061
Study Brief:
Protocol Section:
NCT01231061