Feasibility of combined Focused Ultrasound and Radiotherapy treatment in patients with painful bone metastasis

Completed

• Conditions: Bone metastases; metastatic bone disease; 10005959; 10027476; 10005944

• Registration Number: NL-OMON48418
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Men and women with age * 18 years;
- Patient capable of giving informed consent and able to attend study visits;
- Uncomplicated painful bone metastases;
- Weight < 140kg and able to fit in the MRI gantry;
- Radiologic evidence of bone metastases from any solid tumor;
- Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area;
- Pain related to the target lesion is refractory to less invasive treatments for pain relief;
- Multiple metastatic lesions, with one predominantly painful lesion (><=2 points higher pain score than other lesions). The lesion should be clearly distinguishable form other painful lesions;
- Device accessible tumors: extremities (excluding joints), pelvis, shoulders, posterior vertebral spine below L5, in selected cases ribs and sternum;
- Target lesion maximum dimension * 8cm;
- Intended target volume visible by non-contrast MR imaging;
- Distance between target and skin * 1cm;
- Numeric Rating Scale (NRS) score ><= 4 or equivalent;
- Life expectancy >3 months.

Exclusion Criteria

- Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia;
- Communication barrier present;
- Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment;
- Unable to tolerate required stationary position during treatment despite adequate pain medication;
- Need for surgery;
- Pregnant woman;
- Pain related to target lesion is predominantly due to fracture or impending fracture;
- Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression);
- Target < 3cm from bladder / bowel / nerve along the beam path and < 1cm in the plane orthogonal to the beam;
- Target in contact with hollow viscera;
- Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum;
- Internal or external fixation device along the proposed HIFU beam path or at the target;
- MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia);
- MRI contrast agent contraindicated (e.g. previous anaphylaxis or Glomerular Filtration Rate < 20 ml/min/1.73m2);
- Sedation contraindicated;
- Previous surgery or minimally invasive treatment at targeted site within the last three months;
- Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator;
- Karnofsky performance score (KPS) < 60%;
- Oligometastatic disease planned for curative treatment;
- Indication for stereotactic radiotherapy (e.g. patients with radioresistent histology such as renal cell, melanoma, sarcoma metastases);
- History of photodermatoses (of the skin overlying the target area);
- Need for remineralisation;
- Previous radiation to same site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome of this study is feasibility of the procedure, in terms of<br /><br>plannability as well as patient-tolerability of the combined treatment within a<br /><br>short time frame (3 hours - 4 days interval).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In addition, pain relief and safety of the combined procedure will be<br /><br>monitored.</p><br>