Bone MetastasesPhase 1NCT00350233
MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
A Phase 1 study testing ExAblate 2000 in people with Bone Metastases, run by InSightec at 2 sites in 2 countries.
Trial summary
The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of 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 2000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2006to Feb 2010
- Phase
- Phase 1
- 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 with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
- Must have persistent pain from at least one site of bone metastases
- Patient with VAS pain score ≥ 4, when VAS test taken without medication, OR
- Patient taking pain-relieving medication for management of bone metastases.
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- Targeted tumor(s) are ExAblate device accessible
- Targeted tumor(s) size is smaller than 8 cm in diameter
- 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
- 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 weight bearing bones or impending fracture
- Targeted tumor is in the vertebral column.
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
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- 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 (weight >250 pounds), etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
- ASA Score>2 (See "Definitions" below)
- 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.
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)
- Patient whose lesion is < 10-mm from the skin
- Patients with < 2-Weeks since chemotherapy
- Patient with < 1-Month since radiation therapy
- Patients with life expectancy < 6-Months
- Patients with surgical stabilization of tumor site with metallic hardware
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California at San Diego
La Jolla, California, 92037
About this study
The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.
Read the detailed description
Bone is the third most common organ involved by metastasic 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 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 bisphosphanates), 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 MRgFUS is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the result of this study the Sponsor will initiate a larger study in an effort to approve metastatic bone tumors as an indication for its MRgFUS ExAblate device.
- Conditions
- Bone Metastases
- Being tested
- ExAblate 2000
- Keywords
- Bone Tumors, Bone Cancer, Prostate Cancer, lung cancer
- Medical subject headings
- Bone Neoplasms, Prostatic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2000Device
| Study group | Role | What they receive |
|---|---|---|
| ExAblate MRgFUS | Experimental | Not described Receives: Device: ExAblate 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine safety of MRgFUS of Bone Metastases
Measured: Within 1 month of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2010
- Study completionFeb 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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
- Christine Chung, M.D., Principal investigator, University of California, San DiegoDavid Gianfelice, M.D., Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350233
- Sponsor's protocol ID
- BM002
- Status last verified
- Sep 2012
- First submitted
- 6 Jul 2006
- Last updated
- 17 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
- ClinicalTrials.gov ID
- NCT00350233
- Acronym / sponsor ID
- BM002
- Conditions
- Bone Metastases
- Keywords
- Bone Tumors, Bone Cancer, Prostate Cancer, lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Jul 2006 (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 objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.
Detailed description
Bone is the third most common organ involved by metastasic 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 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 bisphosphanates), 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 MRgFUS is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the result of this study the Sponsor will initiate a larger study in an effort to approve metastatic bone tumors as an indication for its MRgFUS ExAblate device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate MRgFUS | Experimental | Device: ExAblate 2000 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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 with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
- Must have persistent pain from at least one site of bone metastases
- Targeted tumor(s) are ExAblate device accessible
Key exclusion criteria (22 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 weight bearing bones or impending fracture
- Targeted tumor is in the vertebral column.
- Patients with unstable cardiac status including:
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 | Device | ExAblate MRgFUS |
Primary outcome
Determine safety of MRgFUS of Bone Metastases
Time frame: Within 1 month of 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 17 Sep 2012.
- Sponsor 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.
Christine Chung, M.D. principal investigator
University of California, San Diego
David Gianfelice, M.D. principal investigator
Toronto General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ExAblate 2000 in people with Bone Metastases, run by InSightec at 2 sites in 2 countries.
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 13 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: finished, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determine safety of MRgFUS of Bone Metastases (time frame: Within 1 month of 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 17 Sep 2012.