NL-OMON39361
Completed
Not Applicable
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study. - MR-HIFU for Bone Metastases - Multicenter.
Philips Medical Systems, MR Finland0 sites14 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- bone disseminations.
- Sponsor
- Philips Medical Systems, MR Finland
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women with age \* 18 years.
- •Capable of giving informed consent and able to attend study visits.
- •Weight \< 140 kg.
- •Radiologic evidence of bone metastases from any solid tumor.
- •Diagnosis of dominant painful bone metastasis (NRS \* 4\), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is refused by patient or contra\-indicated.
- •Patient has been on stable pain medication for at least 1 week prior to HIFU treatment date.
- •Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area.
- •Patient has 1\-3 painful lesions, and only the most painful lesion will be treated.
- •Intended Target Volume accessible for MR\-HIFU procedure.
- •Target lesion maximum dimension \* 8 cm.
Exclusion Criteria
- •Planned treatment lesion is a primary bone tumor or due to lymphoma 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.
- •Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight\-bearing bone larger than 50% of bone diameter).
- •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 \< 3 cm from bladder / bowel / nerve along the beam path and \< 1 cm in the plane orthogonal to the beam.
- •Target in contact with hollow viscera.
Outcomes
Primary Outcomes
Not specified
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