Focused Ultrasound and Radiotherapy for Noninvasive Palliative Pain Treatment in Patients with Bone Metastases

Recruiting

Conditions: metastasis in the bone
Bonemetastases
10027476

Registration Number: NL-OMON52529

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 65

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)
Life expectancy > 3 months

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes of the trial will be pain response at 14 days after completion<br /><br>of the treatment, and pain response at 14 days after inclusion. Secondary<br /><br>outcomes include pain scores, toxicity, adverse events, quality of life and<br /><br>survival in the first 6 months after treatment, and cost-effectiveness of the<br /><br>treatments. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include pain scores, toxicity, adverse events, quality of<br /><br>life and survival in the first 6 months after treatment, and cost-effectiveness<br /><br>of the treatments. </p><br>