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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT06746103
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older
* Patients diagnosed with metastatic spinal tumors with one index metastatic site that, confirmed by the treating clinicians, is causing spine pain
* Patients experience at least one type of pain that is of interest of this study, namely, axial non-triggered pain, axial triggered/mechanical pain, radicular non-triggered pain, and radicular triggered/mechanical pain
* At least one type of the pain experienced has an NRS \> 4 of 10
* Patients undergoing surgery and/or radiotherapy
* Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.
* Percutaneous screw fixation counts as instrumented stabilization surgery.
* Any kind of radiotherapy is includable.
* Ability to provide informed consent according to the IRB/EC defined and approved procedures
Exclusion Criteria:
* Estimated survival \< 3 months
* Patients with more than one symptomatic spine metastasis site
o An example is a patient with two metastasis sites: a lumbar metastasis (causing vertebral fracture and epidural compression leading to mechanical lower back pain and static radicular pain to legs) and a cervical metastasis (causing tumor-related pain at the neck).
* Patients with other sources of pain that may confound the measurement of the primary outcome
o An example is a patient with liver metastasis which causes visceral pain that can confound the thoracic spinal pain caused by the spinal metastasis.
* Patients undergoing the following treatments alone without the surgeries listed in the inclusion criteria or radiotherapy
* Cement augmentation, vertebroplasty, kyphoplasty, and other emerging interventions such as local ablative technique
* Chemotherapy or systemic therapy alone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06746103
Study Brief:
Protocol Section:
NCT06746103