Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial

Table 2 Inclusion and exclusion criteria of the FURTHER trial

Inclusion criteria	Exclusion criteria
Age ≥ 18 years	Previous surgery on the target location
Patient capable of giving informed consent	Neurological symptoms due to nerve involvement of target lesion
Referral to radiotherapy department due to painful metastatic bone lesion (NRS ≥ 4)	Need for surgery of targeted location due to (impending) pathological fracture
Pain from the target lesion is distinguishable from other lesions *	Unavoidable critical structures or dense tissues in the target area ***
Target lesion location is accessible for MR-HIFU and EBRT **	Curative intention of treatment plan
Target lesion is visible on pre-treatment MR or CT imaging, with a maximum diameter of 8 cm	Contraindications MRI or sedation
Participant able to fit in the MRI gantry	Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
Reasonable performance score (KPS ≥ 50% or Zubrod/ECOG/WHO < 3)	Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
Life expectancy ≥ 3 months

^*Solitary painful metastatic bone lesion or multiple metastatic lesions with one predominantly painful target lesion (≥ 2 points higher pain score than other lesions)
^**For example, extremities, pelvis (os pubis, os ilium, os ischium, sacrum, acetabulum), shoulders, in selected cases ribs and sternum (if no lung tissue in HIFU beam path)
^***As judged by the operator, e.g., nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g., hollow viscera), and (external) fixation device
ECOG Eastern Cooperative Oncology Group, KPS Karnofsky Performance Score, HIFU high-intensity focused ultrasound, EBRT external beam radiotherapy

ISSN: 1745-6215