Bone MetastasesNCT06487013
Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases: A Pivotal Study
A study testing ArcBlate Focused Ultrasound Ablation System in people with Bone Metastases, run by EpiSonica at 4 sites in Taiwan.
Trial summary
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- ArcBlate Focused Ultrasound Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesTaiwan
- Study dates
- 8 Dec 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- No radiation therapy to targeted (most painful) lesion in the past two weeks before treatment.
- 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.
- 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).
- MRI Screening (Screening 2):
- Targeted tumor(s) are ArcBlate MRgHIFU accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5).
- Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
- Targeted (treated) tumor clearly visible by non-contrast MRI, and ArcBlate MRgHIFU accessible.
- Sonication Screening (Screening 3):
- Subjects could tolerate planned test sonications per randomized treatment.
Who cannot join
- Provisional Screening (Screening 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.
- Patients with unstable cardiac status including:
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- 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.
- Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
- Known intolerance or allergies to the MRI contrast agent (e.g., Gadolinium or Magnevist) and Computed Tomography (CT) contrast agent including advanced kidney disease.
- Severe cerebrovascular disease (multiple CerebroVascular Accident (CVA) or CVA within 6 months).
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.).
- Are participating or have participated in another clinical trial in the last 30 days.
- Patients initiating a new chemotherapy regime, or radiation (for the targeted most painful lesion) within the last 2 weeks before treatment.
- Patients unable to communicate with the investigator and staff. (16) Patients with persistent undistinguishable pain (pain source unidentifiable).
- The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.
- Patients with calcified treatment area. (19) Pregnant women.
- MRI Screening (Screening 2):
- Target (treated) lesion is less than 10-mm from nerve bundles, bowels or bladder.
- Extensive scarring in the energy path of the planned treatment area
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites, 4 recruiting
- Not yet recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
- Not yet recruiting
National Taiwan University Hospital
Taipei, 100
- Not yet recruiting
Chang Gung Memorial Hospital - Linkou
Taoyuan, 333
About this study
Official title: A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
Read the detailed description
Pain palliation of bone metastasis through localized denervation by thermal ablation.
- Conditions
- Bone Metastases
- Being tested
- ArcBlate Focused Ultrasound Ablation System, Sham MRgHIFU treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArcBlate Focused Ultrasound Ablation SystemDevice
MR-guided High Intensity Focused Ultrasound (MRgHIFU)
Sham MRgHIFU treatmentOther
Sham MRgHIFU treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham MRgHIFU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Complete response (CR): Pain score 0 without analgesic increase.
- 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.
Measured: at 30 days after treatment
Secondary outcomes (6)
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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within the first 90 days within treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start8 Dec 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EpiSonica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487013
- Sponsor's protocol ID
- CTP-BM-22-01
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
- ClinicalTrials.gov ID
- NCT06487013
- Acronym / sponsor ID
- CTP-BM-22-01
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- EpiSonicaIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
Detailed description
Pain palliation of bone metastasis through localized denervation by thermal ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRgHIFU treatment arm | Experimental | Device: ArcBlate Focused Ultrasound Ablation SystemSubjects 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. |
| Sham treatment arm | Sham comparator | Other: Sham MRgHIFU treatmentSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provisional Screening (Screening 1):
- 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.
- MRI Screening (Screening 2):
Key exclusion criteria (22 listed)
- Provisional Screening (Screening 1):
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArcBlate Focused Ultrasound Ablation SystemMR-guided High Intensity Focused Ultrasound (MRgHIFU) | Device | MRgHIFU treatment arm |
| Sham MRgHIFU treatmentSham MRgHIFU treatment | Other | Sham treatment arm |
Primary outcome
Pain response rate to therapy at 30 days after treatment
Time frame: 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.
6 secondary outcomes
Change from baseline in NRS pain score (0-10 scale)
Time frame: at 1, 3, 7, 14, 30, 60 and 90 days after treatment
Change from baseline in MEDD intake
Time frame: at 7, 14, 30, 60 and 90 days after treatment
Change from baseline in Brief Pain Inventory (BPI-QoL)
Time frame: at 30, 60 and 90 days after treatment
Pain response rate to therapy
Time frame: at 60 and 90 days after treatment
Quality of Life as measured by EORTC QLQ-C15-PAL questionnaire
Time frame: at 30, 60 and 90 days after treatment
Total number of Adverse Events (AEs)
Time frame: within the first 90 days within treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArcBlate Focused Ultrasound Ablation System in people with Bone Metastases, run by EpiSonica at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng-Xian Yan (+886-3-5712354, angelay@episonica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain response rate to therapy at 30 days after treatment (time frame: at 30 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.