Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases

Summary

The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.

Eligibility

Inclusion Criteria:

* Patient capable of giving informed consent
* Age ≥ 18 years
* Painful metastatic bone lesion (NRS \> 2)
* Patient-localised pain with a distinct pathological substrate on recent CT/MRI
* Target lesion location is sufficiently accessible for MR-HIFU to expect clinical response, as judged by the (intervention) radiologist
* Participant has a reasonable performance score (KPS ≥ 50% or Zubrod/ECOG/WHO \< 3)
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Participant is not able to fit in the MR gantry
* Need for surgery of targeted location due to (impending) pathological fracture
* Unavoidable critical structures or dense tissues in target area
* Contra-indications for MRI or sedation/anesthesia
* Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
* Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment

All patients meeting the FURTHER in- and exclusion criteria as described above will be included in this study, either in the FURTHER RCT or FUTHER Registry. The following inclusion criteria are used to decide upon the arm patients will participate in. If patients meet all of the following RCT inclusion criteria, they will be asked to participate in the FURTHER RCT. Alternatively, patients who do not meet one or more of these criteria will be asked to participate in the FURTHER Registry.

* Painful bone lesion (NRS ≥ 4)
* Indication for EBRT treatment of a bone lesion
* Exclusively palliative intention of EBRT treatment plan
* No previous surgery on the target location
* No neurological symptoms due to nerve involvement of target lesion
* No (impending) pathological fracture)
* EBRT replacable by MR-HIFU based on medical history or phyiscal findings judged by multidisciplinary team
* Target lesion location is completely accessible for MR-HIFU

Conditions10

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