CancerNCT01964677
MR-HIFU for Bone Metastases
A study testing Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) in people with Cancer and Bone Metastases, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases. Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Bone Metastases
- What is being tested?
- Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to 14 Nov 2016
- 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
- radiologic evidence of bone metastases from any solid tumour
- diagnosis of dominant painful bone metastasis
- target lesion less than 8cm
Who cannot join
- primary bone tumours rather than metastases
- Inability to tolerate stationary position during treatment
- pregnancy
- MRI incompatible metal implants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation.
The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases
- Conditions
- Cancer, Bone Metastases
- Being tested
- Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
- Keywords
- Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)Device
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU of painful bone metastases | Experimental | Not described Receives: Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response
Measured: 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJan 2014
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems
- Responsible party
- Principal investigator, NdeSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Nandita deSouza, Professor, Principal investigator, ICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964677
- Sponsor's protocol ID
- 12/LO/0424 CCR3772
- Status last verified
- Aug 2017
- First submitted
- 15 Oct 2013
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
- ClinicalTrials.gov ID
- NCT01964677
- Acronym / sponsor ID
- 12/LO/0424 CCR3772
- Conditions
- Cancer, Bone Metastases
- Keywords
- Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Philips Medical Systems
- Study start
- Jan 2014
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 17 Oct 2013 (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 aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation.
The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-HIFU of painful bone metastases | Experimental | Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- radiologic evidence of bone metastases from any solid tumour
- diagnosis of dominant painful bone metastasis
- target lesion less than 8cm
Key exclusion criteria (4 listed)
- primary bone tumours rather than metastases
- Inability to tolerate stationary position during treatment
- pregnancy
- MRI incompatible metal implants
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 Image-guided High Intensity Focused Ultrasound (MR-HIFU) | Device | MR-HIFU of painful bone metastases |
Primary outcome
Pain response
Time frame: 30 days 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 22 Aug 2017.
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
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.
Nandita deSouza, Professor principal investigator
ICR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) in people with Cancer and Bone Metastases, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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 3 inclusion and 4 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 22 Aug 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 United Kingdom. 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?
Pain response (time frame: 30 days 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 22 Aug 2017.