Magnetic Resonance Guided Interventional ProceduresPhase 4NCT03086824
A Safety Evaluation of MR-guided Focused Ultrasound Treatment for Palliative Pain Control of Bone Metastases
A Phase 4 study testing magnetic resonance-guided focused ultrasound in people with Magnetic Resonance Guided Interventional Procedures, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the safety and effectiveness of subjects receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases. This study will evaluate treatment response and clinically significant adverse events. Other relevant data may be documented as well. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Magnetic Resonance Guided Interventional Procedures
- What is being tested?
- magnetic resonance-guided focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2014to Dec 2017
- Phase
- Phase 4
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 20 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: Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy.
- Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
- Targeted bone/tumor interface 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 whose targeted lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
Show all 10Show fewer
- Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible.
- Patients on ongoing chemotherapy regimen at the time of eligibility: 1) with same chemotherapy regimen (as documented from patient medical dossier, 2) worst pain NRS still ≥ 4, and 3) do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
- No radiation therapy to targeted (most painful) lesion in the past two weeks.
- Bisphosphonate intake should remain stable throughout the study duration. -
Who cannot join
- Patients who either Need surgical stabilization of the affected bony structure or Targeted tumor is at an impending fracture site or Surgical stabilization of tumor site with metallic hardware.
- KPS (Karnofsky performance scale) Score < 60.
- Unable to communicate sensations during the ExAblate treatment.
- Target (treated) tumor is less then 10-mm from nerve bundles, bowels or bladder.
- Patients with acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months).
Show all 10Show fewer
- Patients with unstable cardiac status (e.g. unstable angina pectoris, myocardial infarction within 6 months, congestive heart failure NYHA Class IV, on arrhythmic drugs).
- Severe hypertension (diastolic BP > 100 mmHg on medication).
- Patients on dialysis.
- Patients with standard contraindications for MRI or MRI contrast agents. -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Radiation Oncology, Taipei Medical University Hospital
Taipei, Taiwan, 110
About this study
The purpose of this study is to investigate the safety and effectiveness of subjects receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases. This study will evaluate treatment response and clinically significant adverse events. Other relevant data may be documented as well.
Read the detailed description
This proposed study will be performed in full compliance with all applicable privacy rules and regulations, and their implementations at participating site(s). All subjects planned to undergo the MRgFUS procedure at Taipei Medical University Hospital will be offered informed consent so they can be included in this Study.
- Being tested
- magnetic resonance-guided focused ultrasound
- Keywords
- Bone Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance-guided focused ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| MRgFUS | Experimental | Patients with painful bone metastases receiving magnetic resonance-guided focused ultrasound treatment. Receives: Device: magnetic resonance-guided focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treated-related Adverse Events
Measured: 12-months
Secondary outcomes (2)
Change from baseline Quality of Life Questionnaire
Measured: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
Change from baseline Pain Score
Measured: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start12 Dec 2014
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance Guided Interventional ProceduresStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo-Ting Tsai, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086824
- Sponsor's protocol ID
- TMU-SHH-2014-001
- Status last verified
- Mar 2017
- First submitted
- 7 Dec 2016
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Evaluation of MR-guided Focused Ultrasound Treatment for Palliative Pain Control of Bone Metastases
- ClinicalTrials.gov ID
- NCT03086824
- Acronym / sponsor ID
- TMU-SHH-2014-001
- Keywords
- Bone Metastasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- Dec 2017 (estimated)
- First posted
- 22 Mar 2017 (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.
The purpose of this study is to investigate the safety and effectiveness of subjects receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases. This study will evaluate treatment response and clinically significant adverse events. Other relevant data may be documented as well.
Detailed description
This proposed study will be performed in full compliance with all applicable privacy rules and regulations, and their implementations at participating site(s). All subjects planned to undergo the MRgFUS procedure at Taipei Medical University Hospital will be offered informed consent so they can be included in this Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgFUS | Experimental | Device: magnetic resonance-guided focused ultrasoundPatients with painful bone metastases receiving magnetic resonance-guided focused ultrasound treatment. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women age 20 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: Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy.
- Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
- Targeted bone/tumor interface 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 (10 listed)
- Patients who either Need surgical stabilization of the affected bony structure or Targeted tumor is at an impending fracture site or Surgical stabilization of tumor site with metallic hardware.
- KPS (Karnofsky performance scale) Score < 60.
- Unable to communicate sensations during the ExAblate treatment.
- Target (treated) tumor is less then 10-mm from nerve bundles, bowels or bladder.
- Patients with acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
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 |
|---|---|---|
| magnetic resonance-guided focused ultrasound | Device | MRgFUS |
Primary outcome
Treated-related Adverse Events
Time frame: 12-months
2 secondary outcomes
Change from baseline Quality of Life Questionnaire
Time frame: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
Change from baseline Pain Score
Time frame: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Individual participant dataSharing planned: Yes
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 4 study testing magnetic resonance-guided focused ultrasound in people with Magnetic Resonance Guided Interventional Procedures, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Mar 2017. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Treated-related Adverse Events (time frame: 12-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 22 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.