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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT02407795
Eligibility Criteria:
Inclusion Criteria:
* solid tumor with radiological diagnosis of spinal metastases
* pain score minimum 2 on 11-point scale
* maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor at current level of interest
* No or mild neurological signs (radiculopathy, dermatomal sensory change and muscle strength of involved extremity)
* Karnofsky performance ≥60
* WHO ≤2
* life expectancy \> 6 weeks
* age ≥18
* non-pregnant, non-lactating female patients
Exclusion Criteria:
* history of previous radiotherapy to the spine at current level of interest
* spinal instability or neurological deficit
* pathological fracture or impending fracture needing fixation
* prior surgery to the spine at current level of interest
* clinical signs of spinal cord compression or severe neurological deficits
* patients with a pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely
* patients unable to undergo MRI
* earlier nuclear medicine treatment
* pregnancy
* altered mental status that would prohibit the understanding and giving of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02407795
Study Brief:
Protocol Section:
NCT02407795