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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT03479151
Eligibility Criteria:
Inclusion Criteria:
* Patients with painful bony metastatic disease
* Target bony metastatic lesion is painful (NRSā„4)
* Intended target region accessible for MRgHIFU treatment (usually not skull or spinal metastases above the sacrum)
* Intended target region visible on non-contrast MR imaging
Exclusion Criteria:
* MRI contra-indicated (e.g. by incompatible metal implants, claustrophobia, or because BMI precludes accommodation in the MR scanner)
* Pregnancy
* Sedation contra-indicated
* Critical anatomical structure cannot be avoided along the beam path or the at the target (can be assessed at screening)
* Internal or external fixation device along the beam path or at the target
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03479151
Study Brief:
Protocol Section:
NCT03479151