Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases: A Pivotal Study
NCT Number: NCT06487013
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Metastases
Interventions: DEVICE: ArcBlate Focused Ultrasound Ablation System|OTHER: Sham MRgHIFU treatment
Sponsor: EpiSonica
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-12-08
Completion Date: 2025-09-30
Locations: Far Eastern Memorial Hospital, New Taipei City, 220, Taiwan|Taichung Veterans General Hospital, Taichung, 407, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Chang Gung Memorial Hospital - Linkou, Taoyuan, 333, Taiwan

Summary:
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases

Primary Outcome Measures: 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., at 30 days after treatment
Secondary Outcome Measures: 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")., at 1, 3, 7, 14, 30, 60 and 90 days after treatment|Change from baseline in MEDD intake, The changes of MEDD intake between post-treatment and pre-treatment., at 7, 14, 30, 60 and 90 days after 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., at 30, 60 and 90 days after treatment|Pain response rate to therapy, Patients with Complete response (CR) or Partial response (PR) are defined as responders to therapy., at 60 and 90 days after treatment|Quality of Life as measured by EORTC QLQ-C15-PAL questionnaire, The QLQ-C15-PAL contains seven symptom scales (dyspnoea, pain, insomnia, fatigue, appetite loss, nausea and vomiting, and constipation) and three functional scales (physical functioning, emotional functioning, and overall QoL), which were identified as being relevant to the palliative population. Items on the QLQ-C15-PAL questionnaire are rated from 1 (not at all) to 4 (very much), with the exception of the overall QoL status item, which was rated from 1 (very poor) to 7 (excellent). A higher score for the symptom scales represents a higher level of symptomatology and, therefore, a decreased QoL. By contrast, a higher score for the functional scales represents a higher level of functionality and, therefore, an increased QoL. Each scale was transformed to a score ranging from 0 to 100, according to their respective scoring manual., at 30, 60 and 90 days after treatment|Total number of Adverse Events (AEs), Total numbers of complications and AEs, including unintended lesions that occur as a result of treatment with MR-HIFU., within the first 90 days within treatment