A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
Men and women aged 18 and older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at enrollment.
Patients who are able and willing to give consent and able to attend all study visits.
Patients who are suffering from painful bone metastases.
need surgical stabilization of the affected bony structure (>7 fracture risk score), Or
targeted tumor is at an impending fracture site (>7 on fracture risk score), Or
patients with surgical stabilization of tumor site with metallic hardware. (2) Targeted (treated) lesion is in the skull. (3) Patients on dialysis. (4) Patients with life expectancy < 3-Months. (5) Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
Unstable angina pectoris on medication,
Parallel
ArcBlate Focused Ultrasound Ablation System
DeviceMR-guided High Intensity Focused Ultrasound (MRgHIFU)
Sham MRgHIFU treatment
Other interventionSham MRgHIFU treatment
Pain response rate to therapy at 30 days after treatment
Pain response rate is assessed by composite endpoint of change from baseline in worst Numerical Rating Scale (NRS) pain score (0-10 scale) and morphine equivalent daily dose (MEDD) intake. Patients with Complete response (CR) or Partial response (PR) are defined as responders to therapy. 1. Complete response (CR): Pain score 0 without analgesic increase. 2. Partial response (PR): Pain reduction of 2 or more without analgesic increase; or analgesic reduction of 25% without pain increase. The proportion of responders of the subjects who completed treatment is defined as the pain response rate of this study.
Change from baseline in NRS pain score (0-10 scale)
The changes of NRS pain score between post-treatment and pre-treatment. The pain NRS is a single 11-point numeric scale (0-10 scale), with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Change from baseline in MEDD intake
The changes of MEDD intake between post-treatment and pre-treatment.
Change from baseline in Brief Pain Inventory (BPI-QoL)
The changes of BPI between post-treatment and pre-treatment. The BPI is used to rapidly assess the severity of pain and the impact of pain on daily functions. The BPI has seven interference items, such as general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The assessment areas of the BPI include severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.
Pain response rate to therapy
Patients with Complete response (CR) or Partial response (PR) are defined as responders to therapy.
