Actively Recruiting
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
Led by EpiSonica · Updated on 2024-07-05
100
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies the use of ArcBlate palliative treatment for patients suffering from painful bone metastases. It aims to evaluate how effective and safe the ArcBlate Focused Ultrasound Ablation System is in reducing pain caused by bone metastases by using localized thermal ablation to denervate the affected area. Patients included are adults with painful bone metastases who have not responded well to other pain treatments and who meet specific health and imaging criteria. Participants are randomly assigned to one of two groups: the experimental group receiving MR-guided High Intensity Focused Ultrasound (MRgHIFU) treatment using the ArcBlate system, or a control group receiving a sham MRgHIFU treatment without active ultrasound energy. Treatments occur after passing screening procedures including MRI and sonication tolerance tests. The study includes follow-up visits for up to 90 days after treatment to monitor effects and safety. During the study, participants will have their pain levels assessed at multiple points using the Numeric Rating Scale (NRS) and other questionnaires measuring pain, medication use, and quality of life. Researchers will monitor adverse events and changes in pain medication use. The primary measure is the pain response rate at 30 days after treatment. Participants will be evaluated through MRI and clinical assessments, with ongoing monitoring through 90 days following treatment to assess safety and effectiveness.
CONDITIONS
Brief 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...
- Adults aged 18 years 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 relief
- Pain score of 4 or higher on a 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 without plans to start new chemotherapy
- No radiation therapy to the targeted lesion within the past 2 weeks
- Stable bisphosphonate intake during the study
- Have 1 to 5 painful lesions with only the most painful lesion treated
- Persistent distinguishable pain at one treatment site, with at least 2 points higher pain than other sites on the pain scale
- Targeted tumors accessible by ArcBlate MRgHIFU and located in specified bones and spinal vertebrae
- Lesion located more than 10 mm from the skin and clearly visible on non-contrast MRI
- Able to tolerate planned test sonications
You will not qualify if you...
- Need surgical stabilization of the affected bone or have surgical hardware at the tumor site
- Targeted lesion located in the skull
- Patients on dialysis
- Life expectancy less than 3 months
- Acute medical conditions hindering study completion
- Unstable cardiac conditions or on certain heart medications
- Severe hypertension (diastolic > 100 mmHg despite medication)
- Contraindications for MRI including incompatible metal implants or size limitations
- Active infections or uncontrolled severe diseases
- Known allergies or intolerance to MRI or CT contrast agents
- Severe cerebrovascular disease or recent stroke
- Unable or unwilling to tolerate prolonged stationary position during treatment
- Participation in another clinical trial within the last 30 days
- Recent initiation of chemotherapy or radiation to the targeted lesion within 2 weeks
- Unable to communicate with study staff
- Persistent undistinguishable pain
- Target lesion is not sufficiently more painful than other lesions
- Calcified treatment area
- Pregnant women
- Lesion too close to nerve bundles, bowels, or bladder
- Extensive scarring in planned treatment energy path
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive either the ArcBlate Focused Ultrasound Ablation System treatment or a sham treatment to relieve pain from bone metastases.
1 treatment visit (in-person)
Duration - 90 days after treatment
Participants are monitored for pain relief and safety after treatment.
7 follow-up visits at 1, 3, 7, 14, 30, 60, and 90 days post-treatment (in-person or remote)
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here