Actively Recruiting
Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases: A Pivotal Study
Led by EpiSonica · Updated on 2024-07-05
100
Participants Needed
4
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
CONDITIONS
Official Title
Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases: A Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 and older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at enrollment
- Able and willing to give consent and attend all study visits
- Suffering from painful bone metastases
- Refuse other accepted treatments such as surgery or radiotherapy for pain palliation
- Pain score of 4 or higher on the NRS (0-10 scale) regardless of medication
- Able to communicate sensations during ArcBlate MRgHIFU treatment
- On stable systemic anticancer treatment for at least 2 weeks before treatment
- No radiation therapy to targeted lesion in the past two weeks before treatment
- Stable bisphosphonate intake throughout the study
- Have 1 to 5 painful lesions; only the most painful lesion will be treated
- Persistent distinguishable pain at one treatment site, with pain from other sites at least 2 points less intense on the NRS
- Targeted tumors accessible by ArcBlate MRgHIFU and located in ribs, extremities (excluding joints), pelvis, shoulders, or specified spinal vertebrae
- Target lesion on bone with bone-lesion interface deeper than 10 mm from the skin
- Target lesion clearly visible by non-contrast MRI and accessible by ArcBlate MRgHIFU
- Able to tolerate planned test sonications during treatment
You will not qualify if you...
- Need surgical stabilization of affected bone (fracture risk score >7) or have surgical stabilization with metallic hardware
- Targeted lesion located in the skull
- Patients on dialysis
- Life expectancy less than 3 months
- Acute medical conditions hindering study completion (e.g., pneumonia, sepsis)
- Unstable cardiac conditions including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure requiring medication, or use of anti-arrhythmic drugs
- Severe hypertension (diastolic BP >100 mmHg on medication)
- Standard contraindications for MRI such as non-MRI compatible implanted devices or size limitations
- Active infection or severe uncontrolled hematological, neurological, or other diseases
- Known allergies or intolerance to MRI or CT contrast agents
- Severe cerebrovascular disease (multiple strokes or stroke within 6 months)
- Unable or unwilling to tolerate prolonged stationary position during treatment (~2 hours)
- Participation in another clinical trial within the last 30 days
- Initiation of new chemotherapy or radiation to target lesion within 2 weeks before treatment
- Unable to communicate with study staff
- Persistent undistinguishable pain source
- Target lesion pain not at least 2 points higher than other painful lesions on NRS
- Calcified treatment area
- Pregnancy
- Target lesion less than 10 mm from nerve bundles, bowels, or bladder
- Extensive scarring in the treatment energy path
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
Not Yet Recruiting
2
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan, 100
Not Yet Recruiting
4
Chang Gung Memorial Hospital - Linkou
Taoyuan, Taiwan, 333
Not Yet Recruiting
Research Team
F
Feng-Xian Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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