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Trial Title:
Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases: A Pivotal Study
NCT ID:
NCT06487013
Condition:
Bone Metastases
Conditions: Official terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
ArcBlate Focused Ultrasound Ablation System
Description:
MR-guided High Intensity Focused Ultrasound (MRgHIFU)
Arm group label:
MRgHIFU treatment arm
Intervention type:
Other
Intervention name:
Sham MRgHIFU treatment
Description:
Sham MRgHIFU treatment
Arm group label:
Sham treatment arm
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Provisional Screening (Screening 1):
1. Men and women aged 18 and older.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at
enrollment.
3. Patients who are able and willing to give consent and able to attend all study
visits.
4. Patients who are suffering from painful bone metastases.
5. Patients who refuse other accepted available treatments such as surgery or
radiotherapy for pain palliation.
6. Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
7. Able to communicate sensations during the ArcBlate MRgHIFU treatment.
8. 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).
- MRI Screening (Screening 2):
1. 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).
2. Patient whose targeted (treated) lesion is on bone and the interface between
the bone and lesion is deeper than 10-mm from the skin.
3. Targeted (treated) tumor clearly visible by non-contrast MRI, and ArcBlate
MRgHIFU accessible.
- Sonication Screening (Screening 3):
1. Subjects could tolerate planned test sonications per randomized treatment.
Exclusion Criteria:
- 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.
(14) Patients initiating a new chemotherapy regime, or radiation (for the targeted
most painful lesion) within the last 2 weeks before treatment.
(15) Patients unable to communicate with the investigator and staff. (16) Patients
with persistent undistinguishable pain (pain source unidentifiable).
(17) The targeted tumor is less than 2 points more painful compared to other painful
lesions on the site specific NRS.
(18) Patients with calcified treatment area. (19) Pregnant women.
- MRI Screening (Screening 2):
1. Target (treated) lesion is less than 10-mm from nerve bundles, bowels or
bladder.
2. Extensive scarring in the energy path of the planned treatment area
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Far Eastern Memorial Hospital
Address:
City:
New Taipei City
Zip:
220
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
407
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Chang Gung Memorial Hospital - Linkou
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Not yet recruiting
Start date:
December 8, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
EpiSonica
Agency class:
Industry
Source:
EpiSonica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06487013
