Bone MetastasesBM005NCT03547557
MR Guided Focused Ultrasound Surgery in the Treatment of Pain From Bone Tumors w/ the ExAblate 2000 Strappable System
A study testing Exablate 2000 strappable system in people with Bone Metastases, run by InSightec at 1 site in Israel.
Trial summary
A Feasibility Study To Evaluate the Safety and initial Effectiveness of MR guided Focused Ultrasound Surgery in the Treatment of pain resulting from Metastatic Bone Tumors with the ExAblate 2000 strappable system. 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?
- Exablate 2000 strappable system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Mar 2009
- 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
- Men and women age 18 and older
- Patients who are able and willing to give written consent and are able to attend all study visits
- Patients with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
- Patients with persistent pain from at least one site of bone metastases and are able to distinguish the pain from other painful sites oPatient with localized VAS pain score ≥ 4, at the target tumor oIn case of patients with more than one painful site, VAS pain score at the target site should exceed VAS pain score at any other site by at least two units.
- Targeted tumor(s) are ExAblate device 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)
- Targeted tumor(s) size is smaller than 8 cm in diameter on bone surface
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- Patient whose lesion is on bone and is ≥ 10-mm from the skin.
- Tumor(s) clearly visible by non-contrast MRI
- Able to communicate sensations during the MRgFUS ExAblate treatment
- KPS ≥60 (See "Definitions" below)
- At least 2 weeks since chemotherapy
- At least 1 month since radiation therapy
Who cannot join
- Diffuse skeletal tumoral spread as evaluated by imaging.
- Patients who need pre-treatment surgical stabilization of the affected bony structure.
- Targeted tumor is in impending fracture
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication oPatients with documented myocardial infarction within six months of protocol entry oCongestive heart failure requiring medication (other than diuretic) oPatients on anti-arrhythmic drugs
- Severe hypertension (diastolic BP > 100 on medication)
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- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations; weight >110 kg, etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
- Extensive scarring in an area in the path of energy planned passage to the treatment area
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- Patients on anti-coagulation therapy or those with an underlying bleeding disorder
- Severely abnormal coagulation (INR>1.5)the upper limit
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
- Patients with life expectancy < 6-Months
- Patients with surgical stabilization of tumor site with metallic hardware
- Lesion is less then 5mm from a nerve.
- Pregnant or lactating women
- Patients that are currently participating or have participated in another clinical trial in the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2000 Strappable System
A Feasibility Study To Evaluate the Safety and initial Effectiveness of MR guided Focused Ultrasound Surgery in the Treatment of pain resulting from Metastatic Bone Tumors with the ExAblate 2000 strappable system.
Read the detailed description
Bone is the third most common organ involved by metastatic disease behind lung and liver. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both of these tumors, as well as their prolonged clinical courses.
Post cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased. Patients with bone metastasis from breast cancer have an average 2-year survival from the time of presentation with their first bone lesion. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death.
Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphonates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described: 1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4) Skeletal stabilization.
The study hypothesis is that treatment with the MRgFUS, which is delivered by a strappable transducer, is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the results of this study the Sponsor will initiate a larger study in an attempt to obtain regulatory approval for the treatment of metastatic bone tumors as an indication for the MRgFUS ExAblate strappable system.
- Conditions
- Bone Metastases
- Being tested
- Exablate 2000 strappable system
- Keywords
- Bone Tumors
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate 2000 strappable systemDevice
| Study group | Role | What they receive |
|---|---|---|
| ExAblate MRgFUS | Experimental | Not described Receives: Device: Exablate 2000 strappable system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
adverse event incidence and severity
Measured: Within 3 months of treatment
Change in pain Numerical Rating Scale (NRS) from pre-treatment to post treatment
NRS scale 0-10
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study startJan 2007
- Primary completionFeb 2009
- Study completionMar 2009
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.
- More trials run by InSightecThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. R. Catane, Principal investigator, Sheba Medical Center-Oncology Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547557
- Sponsor's protocol ID
- BM005
- Acronym
- BM005
- Status last verified
- Jun 2018
- First submitted
- 13 Sep 2012
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2000 Strappable System
- ClinicalTrials.gov ID
- NCT03547557
- Acronym / sponsor ID
- BM005 / BM005
- Conditions
- Bone Metastases
- Keywords
- Bone Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Jun 2018 (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 Feasibility Study To Evaluate the Safety and initial Effectiveness of MR guided Focused Ultrasound Surgery in the Treatment of pain resulting from Metastatic Bone Tumors with the ExAblate 2000 strappable system.
Detailed description
Bone is the third most common organ involved by metastatic disease behind lung and liver. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both of these tumors, as well as their prolonged clinical courses.
Post cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased. Patients with bone metastasis from breast cancer have an average 2-year survival from the time of presentation with their first bone lesion. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death.
Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphonates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described: 1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4) Skeletal stabilization.
The study hypothesis is that treatment with the MRgFUS, which is delivered by a strappable transducer, is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the results of this study the Sponsor will initiate a larger study in an attempt to obtain regulatory approval for the treatment of metastatic bone tumors as an indication for the MRgFUS ExAblate strappable system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate MRgFUS | Experimental | Device: Exablate 2000 strappable system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women age 18 and older
- Patients who are able and willing to give written consent and are able to attend all study visits
- Patients with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
- Patients with persistent pain from at least one site of bone metastases and are able to distinguish the pain from other painful sites oPatient with localized VAS pain score ≥ 4, at the target tumor oIn case of patients with more than one painful site, VAS pain score at the target site should exceed VAS pain score at any other site by at least two units.
- Targeted tumor(s) are ExAblate device 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)
Key exclusion criteria (18 listed)
- Diffuse skeletal tumoral spread as evaluated by imaging.
- Patients who need pre-treatment surgical stabilization of the affected bony structure.
- Targeted tumor is in impending fracture
- Patients with unstable cardiac status including:
- Severe hypertension (diastolic BP > 100 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 |
|---|---|---|
| Exablate 2000 strappable system | Device | ExAblate MRgFUS |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: Within 3 months of treatment
adverse event incidence and severity
Change in pain Numerical Rating Scale (NRS) from pre-treatment to post treatment
Time frame: 3 months post treatment
NRS scale 0-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Sponsor's Web PageLink provided by the sponsor.
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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.
Prof. R. Catane principal investigator
Sheba Medical Center-Oncology Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate 2000 strappable system in people with Bone Metastases, run by InSightec at 1 site in Israel.
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 12 inclusion and 18 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: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: Within 3 months of treatment). The study lists 2 primary outcomes in all. 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 6 Jun 2018.