Bone CancerPhase 2NCT01085565
Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
A Phase 2 study testing ExAblate 2100 in people with Bone Cancer and Bone Metastases, run by InSightec at 1 site in Israel.
Trial summary
The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Cancer, Bone Metastases, Pain
- What is being tested?
- ExAblate 2100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 2013
- Phase
- Phase 2
- 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 consent and able to attend all study visits
- Patients who are suffering from symptoms of bone metastases
- 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)
- Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors irrespective of medication.
- Patient who's targeted tumors are on bone and bone-lesion interface is more than 1cm from the skin, major nerve or hollow viscera.
- Targeted tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
- Able to communicate sensations during the ExAblate MRgFUS treatment
Who cannot join
- Patients who either:
- Need surgical stabilization of the affected weight bearing bony structure OR
- Targeted tumor is at an impending fracture site of the weigh bearing bone. OR
- Patients with surgical stabilization of tumor site with metallic hardware
- Target tumors-bone interface is less then 1cm from nerve bundles, bowels, skin or bladder.
- Targeted (most painful) tumors:
Show all 28Show fewer
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
- Targeted tumor is in the skull
- Patients on dialysis
- Patients with life expectancy < 6-Months
- Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
- Subjects with Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
- Subjects with Severe Congestive Heart Failure, NYHA class 4.
- Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
- Severe cerebrovascular disease (CVA within last 6 months)
- Severe hypertension (diastolic BP > 100 on medication)
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
- Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
- KPS Score < 60 (See "Definitions" below)
- Patients unable to communicate with the investigator and staff.
- 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 for the palliation of their targeted bone metastasis tumors in the last 30 days
- Patients receiving new chemotherapy regime or radiation to the targeted lesion (s) within the last two weeks
- Patients with persistent undistinguishable pain (pain source unidentifiable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Evaluate the Safety and Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.
Read the detailed description
Bone is the third most common organ involved by metastatic disease behind lung and liver [6]. 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 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.
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 although the primary goal of the use of these therapies are often to address the disease itself), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases [8]. Currently, an off label use of Cryoablation techniques are being tested as another alternative for bone Mets palliation. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described:
- Pain relief
- Preservation and restoration of function
- Local tumor control
- Skeletal stabilization
Treatment with external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain, and results in the palliation of pain for many of these patients. Twenty to 30% of patients treated with radiation therapy do not experience pain relief [9-13]. Re-treatment rates are generally reported in the range of 10-25%. Many patients with relapsed pain or poor response to initial radiation may be lost to follow up or may not be referred back to oncologists for consideration of re-radiation. In addition to relapse and re-treatment, there is an increased risk of pathologic fracture in the peri-radiation period. The fracture rate reported in radiation studies is generally in the range of 1% to 8%. The hyperemic response weakens the adjacent bone and increases the risk of spontaneous fracture. Furthermore, patients who have recurrent pain at a site previously irradiated may not be eligible for further radiation therapy secondary to limitations in normal tissue tolerance. Hesitation on the part of physicians to use a larger dose may be related to increased long-term toxicity. Larger radiation dose produces a greater risk of complications such as fibrosis of normal soft tissue, which can cause a decrement in the quality of life in cases of life expectancy longer than 6 months. There may also be a greater incidence of acute side effects of nausea and vomiting if the treatment field includes the stomach. The percent of patients experiencing vomiting following EBRT ranges from about 5% to 30%.
A palliative treatment for painful bone metastases that is non-invasive, without long-term toxicity and having minimal complications would be a useful tool for treating physicians and also a beneficial option for patients suffering from painful bone metastases. Results of preliminary studies indicate that ExAblate treatment of painful bone metastases may be a beneficial treatment option [14, 15]. The ExAblate system is a non-invasive thermal ablation device used in the coagulation of various types of soft tissue. The ExAblate system has the potential to achieve the first three of the four previously mentioned goals in the treatment of bone tumors; namely pain relief, preservation and restoration of functional levels and local tumor control [11]. The ExAblate system used in the present study is a technological advance over the ExAblate 2000 fixed transducer system in terms of flexibility of use and reduction of positioning related pain to the patients. The ExAblate system used in this study conforms to the patient's body shape at the location of the bone mets location
- Conditions
- Bone Cancer, Bone Metastases, Pain
- Being tested
- ExAblate 2100
- Keywords
- Bone cancer, Bone Metastases, pain palliation, metastasis, breast cancer, lung cancer, prostate cancer, cancer related pain, tumors
- Medical subject headings
- Bone Neoplasms, Pain, Neoplasm Metastasis, Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Cancer Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2100Device
Conformal Bone System
| Study group | Role | What they receive |
|---|---|---|
| Exablate treatment | Experimental | Not described Receives: Device: ExAblate 2100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Evaluate incidence and severity of adverse events associated with ExAblate MRgFUS ExAblate Conformal system used in the palliation of pain due to metastatic bone tumors
Measured: 3 months post treatment
Secondary outcomes (3)
Efficacy
Level of pain relief (measured by Pain Scale)
Measured: 3 months post treatment
Effectiveness
Decrease in analgesics/opiate
Measured: 3 months post treatment
Effectiveness
Improved quality of life (measured by questionnaire)
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 posted12 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085565
- Sponsor's protocol ID
- BM011
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2010
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Safety and Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
- ClinicalTrials.gov ID
- NCT01085565
- Acronym / sponsor ID
- BM011
- Conditions
- Bone Cancer, Bone Metastases, Pain
- Keywords
- Bone cancer, Bone Metastases, pain palliation, metastasis, breast cancer, lung cancer, prostate cancer, cancer related pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Mar 2010 (estimated)
- 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.
The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.
Detailed description
Bone is the third most common organ involved by metastatic disease behind lung and liver [6]. 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 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.
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 although the primary goal of the use of these therapies are often to address the disease itself), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases [8]. Currently, an off label use of Cryoablation techniques are being tested as another alternative for bone Mets palliation. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described:
- Pain relief
- Preservation and restoration of function
- Local tumor control
- Skeletal stabilization
Treatment with external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain, and results in the palliation of pain for many of these patients. Twenty to 30% of patients treated with radiation therapy do not experience pain relief [9-13]. Re-treatment rates are generally reported in the range of 10-25%. Many patients with relapsed pain or poor response to initial radiation may be lost to follow up or may not be referred back to oncologists for consideration of re-radiation. In addition to relapse and re-treatment, there is an increased risk of pathologic fracture in the peri-radiation period. The fracture rate reported in radiation studies is generally in the range of 1% to 8%. The hyperemic response weakens the adjacent bone and increases the risk of spontaneous fracture. Furthermore, patients who have recurrent pain at a site previously irradiated may not be eligible for further radiation therapy secondary to limitations in normal tissue tolerance. Hesitation on the part of physicians to use a larger dose may be related to increased long-term toxicity. Larger radiation dose produces a greater risk of complications such as fibrosis of normal soft tissue, which can cause a decrement in the quality of life in cases of life expectancy longer than 6 months. There may also be a greater incidence of acute side effects of nausea and vomiting if the treatment field includes the stomach. The percent of patients experiencing vomiting following EBRT ranges from about 5% to 30%.
A palliative treatment for painful bone metastases that is non-invasive, without long-term toxicity and having minimal complications would be a useful tool for treating physicians and also a beneficial option for patients suffering from painful bone metastases. Results of preliminary studies indicate that ExAblate treatment of painful bone metastases may be a beneficial treatment option [14, 15]. The ExAblate system is a non-invasive thermal ablation device used in the coagulation of various types of soft tissue. The ExAblate system has the potential to achieve the first three of the four previously mentioned goals in the treatment of bone tumors; namely pain relief, preservation and restoration of functional levels and local tumor control [11]. The ExAblate system used in the present study is a technological advance over the ExAblate 2000 fixed transducer system in terms of flexibility of use and reduction of positioning related pain to the patients. The ExAblate system used in this study conforms to the patient's body shape at the location of the bone mets location
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exablate treatment | Experimental | Device: ExAblate 2100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women age 18 and older
- Patients who are able and willing to give consent and able to attend all study visits
- Patients who are suffering from symptoms of bone metastases
- 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)
- Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors irrespective of medication.
Key exclusion criteria (28 listed)
- Patients who either:
- Target tumors-bone interface is less then 1cm from nerve bundles, bowels, skin or bladder.
- Targeted (most painful) tumors:
- Targeted tumor is in the skull
- Patients on dialysis
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 2100Conformal Bone System | Device | Exablate treatment |
Primary outcome
Safety
Time frame: 3 months post treatment
Evaluate incidence and severity of adverse events associated with ExAblate MRgFUS ExAblate Conformal system used in the palliation of pain due to metastatic bone tumors
3 secondary outcomes
Efficacy
Time frame: 3 months post treatment
Effectiveness
Time frame: 3 months post treatment
Effectiveness
Time frame: 3 months post treatment
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 8 Mar 2016.
- Sponsor's websiteLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ExAblate 2100 in people with Bone Cancer and 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 8 inclusion and 28 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 8 Mar 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (time frame: 3 months post 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 8 Mar 2016.