Bonemetastases metastasis in the bone
Conditions
Interventions
The intervention under study is MR-HIFU alone or in combination with EBRT. The
intervention is aimed at rapid and persistent relief of CIBP.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >= 18 years Patient capable of giving informed consent Painful metastatic bone lesion (NRS >= 2) Patient-localised pain with a distinct pathological substrate on recent CT/MRI Target lesion location is >75% accessible for MR-HIFU Participant able to fit in the MRI gantry Reasonable performance score (KPS > 50% or Zubrod/ECOG/WHO 3 months
Exclusion criteria
Exclusion criteria: Need for surgery of targeted location due to (impending) pathological fracture Unavoidable critical structures or dense tissues in target area * Contra indications MRI or sedation/anaesthesia Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes of the trial will be pain response at 14 days after completion of the treatment, and pain response at 14 days after inclusion. Secondary outcomes include pain scores, toxicity, adverse events, quality of life and survival in the first 6 months after treatment, and cost-effectiveness of the treatments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include pain scores, toxicity, adverse events, quality of life and survival in the first 6 months after treatment, and cost-effectiveness of the treatments. | — |
Countries
Netherlands
Outcome results
None listed