Bone MetastasesNCT00981578
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
A study testing ExAblate 2100 in people with Bone Metastases, run by InSightec at 5 sites in United States.
Trial summary
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors. 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 2100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2009to 14 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- One to 3 painful lesions.
- 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)
- Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated:
Show all 14Show fewer
- o If patient has pain from additional sites that are not planned for treatment, 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(s) to be treated.
- Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ≥ 4) irrespective of medication
- Targeted tumors (most painful) size up to 8 cm in diameter
- Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin.
- Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
- Able to communicate sensations during the ExAblate MRgFUS treatment
- At least 2 weeks since chemotherapy
- No radiation therapy to targeted (most painful) tumors in the past two weeks
Who cannot join
- Patients who either
- Need surgical stabilization of the affected weight bearing bony structure (>7 fracture risk score, see Section 6.9) OR
- Targeted tumor is at an impending fracture site of the weigh bearing bone (>7 on fracture risk score, see Section 6.9).
- OR
- o Patients with surgical stabilization of tumor site with metallic hardware
- More than 3 painful lesions or more than 2 requiring immediate localized treatment
Show all 32Show fewer
- The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.
- 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.
- 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
- 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.
- 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) including advanced kidney disease
- KPS Score < 60 (See "Definitions" below)
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time.)
- Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels or bladder.
- 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 chemotherapy or radiation (i.e., to the targeted lesion (s)) within the last two weeks
- Patients unable to communicate with the investigator and staff.
- Patients with persistent undistinguishable pain (pain source unidentifiable)
- Targeted (most painful) tumors size > 8 cm in diameter
- Targeted (most painful) tumors:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Virginia
Charlottesville, Virginia, 22908
City of Hope
Duarte, California, 91010
Methodist Hospital Research Institute
Houston, Texas, 77030
University of California San Francisco
San Francisco, California, 94107
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Feasibility Study to Evaluate the Safety and Initial 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
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
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 Metastases
- Being tested
- ExAblate 2100
- Keywords
- bone cancer, pain palliation, metastasis, breast cancer, lung cancer, prostate cancer, cancer related pain, tumors
- Medical subject headings
- Bone Neoplasms, 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
Also called Focused ultrasound ablation, MRgFUS
Conformal Bone System
| Study group | Role | What they receive |
|---|---|---|
| ExAblate 2100 Treatment | Experimental | ExAblate 2100 ablation for the treatment of painful bone metastases. Receives: Device: ExAblate 2100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Device Effects
Adverse effects outcomes are reported in the adverse events module.
Measured: 3 months
Secondary outcomes (2)
Change in NRS Pain Scores From Baseline at 3 Months
Efficacy was evaluated by change in Numerical Rating Scale (NRS) pain scores at 3 months post treatment The NRS is an 11 point scale (0-10) with 0 as no pain and 10 as the worst pain. Larger numbers in score change from baseline indicate improvement (decrease) in pain. Two points improvement has been reported as a clinically meaningful.
Measured: Baseline, 3 months
Change Brief Pain Inventory - Pain Interference From Baseline at 3 Months
Quality of life was evaluated using average change from baseline at 3 Months using the Pain Interference section of the Brief Pain Inventory (BPI-Pain Interference). Larger change from Baseline numbers indicate improved function. Pain Interference is the mean of seven questions scored on an 11-point scale of 0 (does not interfere) to 10 (completely interferes). A positive change from Baseline (higher values) at the 3 Month visit indicates improvement or a reduction in pain interference
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Why it stopped: Terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981578
- Sponsor's protocol ID
- BM010
- Status last verified
- Mar 2020
- First submitted
- 21 Sep 2009
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety and Initial 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
- NCT00981578
- Acronym / sponsor ID
- BM010
- Conditions
- Bone Metastases
- Keywords
- bone cancer, pain palliation, metastasis, breast cancer, lung cancer, prostate cancer, cancer related pain, tumors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low enrollment.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate 2100 Treatment | Experimental | Device: ExAblate 2100ExAblate 2100 ablation for the treatment of painful bone metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 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
- One to 3 painful lesions.
- 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 (32 listed)
- Patients who either
- OR
- o Patients with surgical stabilization of tumor site with metallic hardware
- More than 3 painful lesions or more than 2 requiring immediate localized treatment
- The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.
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 2100Also: Focused ultrasound ablation, MRgFUSConformal Bone System | Device | ExAblate 2100 Treatment |
Primary outcome
Number of Adverse Device Effects
Time frame: 3 months
Adverse effects outcomes are reported in the adverse events module.
2 secondary outcomes
Change in NRS Pain Scores From Baseline at 3 Months
Time frame: Baseline, 3 months
Change Brief Pain Inventory - Pain Interference From Baseline at 3 Months
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate 2100 in people with Bone Metastases, run by InSightec at 5 sites in United States.
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 14 inclusion and 32 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: stopped early, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Adverse Device Effects (time frame: 3 months). 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 11 Mar 2020.