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

NCT06487013 | Recruiting

• 1 other identifier: CTP-BM-22-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in NRS pain score (0-10 scale)

  at 1, 3, 7, 14, 30, 60 and 90 days after treatment

• Change from baseline in MEDD intake

  at 7, 14, 30, 60 and 90 days after treatment

• Change from baseline in Brief Pain Inventory (BPI-QoL)

  at 30, 60 and 90 days after treatment

• Pain response rate to therapy

  at 60 and 90 days after treatment

• Quality of Life as measured by EORTC QLQ-C15-PAL questionnaire

  at 30, 60 and 90 days after treatment

Study Arms (2)

MRgHIFU treatment arm

EXPERIMENTAL

Subjects will be randomized to MRgHIFU treatment arm and will pass the Screening Fail criteria preceded in normal fashion to MRgHIFU treatment at the same session.

Device: ArcBlate Focused Ultrasound Ablation System

Sham treatment arm

SHAM COMPARATOR

Subjects who will be randomized to sham treatment arm and passed the Screening Fail Criteria (i.e. MRI Screening and Sonication Screening) will undergo a sham MRgHIFU treatment with sonication energy disabled.

Other: Sham MRgHIFU treatment

Interventions

ArcBlate Focused Ultrasound Ablation System DEVICE

MR-guided High Intensity Focused Ultrasound (MRgHIFU)

MRgHIFU treatment arm

Sham MRgHIFU treatment OTHER

Sham MRgHIFU treatment

Sham treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provisional Screening (Screening 1):
• 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.
• Patients who refuse other accepted available treatments such as surgery or radiotherapy for pain palliation.
• Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
• Able to communicate sensations during the ArcBlate MRgHIFU treatment.
• Patients on ongoing systemic anticancer treatment for at least 2 weeks before treatment:
• with same systemic anticancer treatment (as documented from patient medical dossier), And
• worst pain NRS still ≥ 4, And
• do NOT plan to initiate a new chemotherapy for pain palliation throughout the study duration.
• (9) No radiation therapy to targeted (most painful) lesion in the past two weeks before treatment.
• (10) Bisphosphonate intake should remain stable throughout the study duration. (11) Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated.
• (12) Patients with persistent distinguishable pain associated with 1 site to be treated (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site to be treated).

You may not qualify if:

• Provisional Screening (Screening 1):
• (1) Patients who either
• 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.
• (6) Patients with unstable cardiac status including:
• Unstable angina pectoris on medication,
• Patients with documented myocardial infarction within six months of protocol entry,
• Congestive heart failure requiring medication (other than diuretic),
• Patients on anti-arrhythmic drugs. (7) Severe hypertension (diastolic blood pressure \> 100 mmHg on medication). (8) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (unable to fit into ArcBlate MRgHIFU), etc.
• (9) Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
• (10) Known intolerance or allergies to the MRI contrast agent (e.g., Gadolinium or Magnevist) and Computed Tomography (CT) contrast agent including advanced kidney disease.
• (11) Severe cerebrovascular disease (multiple CerebroVascular Accident (CVA) or CVA within 6 months).
• (12) Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.).
• (13) Are participating or have participated in another clinical trial in the last 30 days.

Sponsors & Collaborators

• EpiSonica: lead

Study Sites (4)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

NOT YET RECRUITING

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

NOT YET RECRUITING

Chang Gung Memorial Hospital - Linkou

Taoyuan District, 333, Taiwan

NOT YET RECRUITING

Central Study Contacts

Feng-Xian Yan

CONTACT

+886-3-5712354; angelay@episonica.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: December 8, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)