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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05167669
Eligibility Criteria:
Inclusion Criteria:
* • Histologically proven cancer;
* cancer-related pain corresponding to a site (or sites) of radiologically confirmed bone metastases with a severity score of at least 2 out of 10 according to the Brief Pain Inventory (NRS scale);
* age ≥ 18 years;
* indication for a palliative course of EBRT;
* osteolytic or mixed (osteoblastic/osteolytic) bone metastases ≤ 5 cm in the largest diameter; target tumours accessibility for device (ribs, extremities, pelvis, shoulders or posterior aspects of spinal vertebra) and at least 1 cm from skin and major nerve bundles;
Exclusion Criteria:
* Inability to provide a written informed consent;
* Karnofsky performance status (KPS) \< 60; presence of clinical or radiological evidence of spinal cord compression, a pathological fracture, or an impending fracture needing surgical fixation;
* previous EBRT to study site (or sites);
* participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry;
* inability to comply with study and follow up procedures;
* patients having metal implants, pacemakers or clustered markers non-MR compatible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Study:
NCT05167669
Study Brief:
Protocol Section:
NCT05167669