CancerHIFU-BoneNCT03479151
Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of 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 primary objective of this study is to determine whether intra- and post-procedural MR changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort of patients with painful bone metastases, who wish to consider MRgHIFU treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2018to 7 Jan 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with painful bony metastatic disease
- Target bony metastatic lesion is painful (NRS≥4)
- Intended target region accessible for MRgHIFU treatment (usually not skull or spinal metastases above the sacrum)
- Intended target region visible on non-contrast MR imaging
Who cannot join
- MRI contra-indicated (e.g. by incompatible metal implants, claustrophobia, or because BMI precludes accommodation in the MR scanner)
- Pregnancy
- Sedation contra-indicated
- Critical anatomical structure cannot be avoided along the beam path or the at the target (can be assessed at screening)
- Internal or external fixation device along the beam path or at the target
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
The primary objective of this study is to determine whether intra- and post-procedural MR changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort of patients with painful bone metastases, who wish to consider MRgHIFU treatment. These patients will be identified in conjunction with the pain and palliative care teams, as well as clinical and medical oncologists. Patients will undergo MRgHIFU treatment using scanning and treatment planning methods that have been established in the patients treated within the multi-centre study. The treatment response rate for the cohort will be recorded. Intra- and post-procedural imaging metrics will be evaluated for their ability to detect tissue changes, which may be indicative of response. Patients will be followed-up for up to 90 days after treatment, and will attend for repeat imaging and pain review at days 30, 60 and 90 after treatment. Any changes in imaging metrics will be compared between responders and non-responders.
Read the detailed description
The primary aim of this study is to investigate whether the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging is indicative of reduction in pain scores (response) 30 days after treatment.
The secondary aims of this study are:
- To record the proportion of patients responding to MRgHIFU treatment at Days 7, 14, 30, 60 and 90 after treatment
- To investigate whether intra-procedural PRFS metrics (thermal dose volume, temperature) are indicative of subsequent treatment response
- To investigate whether intra- or post-procedural changes in ADC or T2 are indicative of subsequent treatment response
- To record adverse events arising as a result of MRgHIFU treatment
- To evaluate the effect of MRgHIFU treatment on patients' quality of life
- To record the time to pain progression and the duration of pain response for patients in this cohort
- To estimate the costs of MRgHIFU treatment
This is an exploratory study, which will recruit n=15 patients into one single cohort. Enrolment of the target population for the study is expected to take approximately 2 years. Patients will be eligible for the study if they wish to consider MRgHIFU treatment for pain palliation of a region of bony metastatic disease that is accessible to the MRgHIFU device. After providing their written informed consent to participate in the study, patients' suitability for treatment will be determined by a combined assessment of clinical review by a pain specialist, and an MR screening investigation to establish lesion targetability. Baseline clinical and imaging metrics will be recorded. Patients who fulfill all inclusion criteria, have none of the exclusion criteria, and who give informed consent, will be scheduled for MRgHIFU treatment to the target lesion. Treatment will be delivered under sedation on a day-case basis, according to protocols already established in our prior study. During treatment delivery, the investigators will assess imaging metrics of tissue change, which may be indicative of subsequent treatment response. Treatment would be expected to take approximately 1-2 hours, and after an observation period of approximately 2-4 hours, the patient will be discharged. Before discharge, follow-up instructions will be given to the patient. Patients' clinical and imaging responses to treatment will then be assessed at follow-up appointments up to 3 months after treatment.
- 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
MRgHIFU treatment will be delivered using a Philips Sonalleve system, which integrates a high intensity phased array focused ultrasound transducer with our Philips 3T Achieva imaging system. An electromechanical transducer positioning system is used to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. The MR system is used to provide images to plan the therapy, and to guide and monitor the thermal ablation with thermal imaging during the treatment.
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU of painful bone metastases | Experimental | Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases 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.
Measure the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging in responders and non-responders.
Measured: Day 30
Secondary outcomes (8)
To report the treatment response rate.
Days 7, 14, 30, 60 and 90
Measured: up to 90 days
To investigate whether ablated tissue volume indicated by Gd-T1W imaging at Day 30 remains stable at Days 60 and 90.
Measured: up to 90 days
.To investigate whether intra-procedural PRFS metrics are different in responders and non-responders at Day 30
PRFS Metrics include thermal dose volume, temperature
Measured: 30 days post treatment
To investigate whether intra- or post-procedural changes in ADC are different in responders and non-responders.
Measured: Day 30
To investigate whether intra- or post-procedural changes in T2 are different in responders and non-responders.
Measured: Day 30
The rate of treatment-related adverse events
Measured: up to 3 months after treatment.
The effect of MRgHIFU treatment on patients' quality of life, recorded using Quality of Life Questionnaires (QLQ's).
using EORTC (European Organization for Research and Treatment of Cancer)- QLQ's
Measured: up to 3 months after treatment.
The costs of MRgHIFU treatment.
Measured: up to 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start16 Mar 2018
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
Why it stopped: CI of study retired on 6.10.2020 and there will be no further efforts to apply for an extension in order to recruit to this study.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems, Cancer Research UK
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Nandita deSouza, Professor, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479151
- Sponsor's protocol ID
- 17/LO/1689 CCR 4733
- Acronym
- HIFU-Bone
- Status last verified
- Oct 2021
- First submitted
- 27 Feb 2018
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases
- ClinicalTrials.gov ID
- NCT03479151
- Acronym / sponsor ID
- HIFU-Bone / 17/LO/1689 CCR 4733
- Conditions
- Cancer, Bone Metastases
- Keywords
- Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: CI of study retired on 6.10.2020 and there will be no further efforts to apply for an extension in order to recruit to this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Philips Medical Systems, Cancer Research UK
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 27 Mar 2018 (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 primary objective of this study is to determine whether intra- and post-procedural MR changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort of patients with painful bone metastases, who wish to consider MRgHIFU treatment. These patients will be identified in conjunction with the pain and palliative care teams, as well as clinical and medical oncologists. Patients will undergo MRgHIFU treatment using scanning and treatment planning methods that have been established in the patients treated within the multi-centre study. The treatment response rate for the cohort will be recorded. Intra- and post-procedural imaging metrics will be evaluated for their ability to detect tissue changes, which may be indicative of response. Patients will be followed-up for up to 90 days after treatment, and will attend for repeat imaging and pain review at days 30, 60 and 90 after treatment. Any changes in imaging metrics will be compared between responders and non-responders.
Detailed description
The primary aim of this study is to investigate whether the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging is indicative of reduction in pain scores (response) 30 days after treatment.
The secondary aims of this study are:
- To record the proportion of patients responding to MRgHIFU treatment at Days 7, 14, 30, 60 and 90 after treatment
- To investigate whether intra-procedural PRFS metrics (thermal dose volume, temperature) are indicative of subsequent treatment response
- To investigate whether intra- or post-procedural changes in ADC or T2 are indicative of subsequent treatment response
- To record adverse events arising as a result of MRgHIFU treatment
- To evaluate the effect of MRgHIFU treatment on patients' quality of life
- To record the time to pain progression and the duration of pain response for patients in this cohort
- To estimate the costs of MRgHIFU treatment
This is an exploratory study, which will recruit n=15 patients into one single cohort. Enrolment of the target population for the study is expected to take approximately 2 years. Patients will be eligible for the study if they wish to consider MRgHIFU treatment for pain palliation of a region of bony metastatic disease that is accessible to the MRgHIFU device. After providing their written informed consent to participate in the study, patients' suitability for treatment will be determined by a combined assessment of clinical review by a pain specialist, and an MR screening investigation to establish lesion targetability. Baseline clinical and imaging metrics will be recorded. Patients who fulfill all inclusion criteria, have none of the exclusion criteria, and who give informed consent, will be scheduled for MRgHIFU treatment to the target lesion. Treatment will be delivered under sedation on a day-case basis, according to protocols already established in our prior study. During treatment delivery, the investigators will assess imaging metrics of tissue change, which may be indicative of subsequent treatment response. Treatment would be expected to take approximately 1-2 hours, and after an observation period of approximately 2-4 hours, the patient will be discharged. Before discharge, follow-up instructions will be given to the patient. Patients' clinical and imaging responses to treatment will then be assessed at follow-up appointments up to 3 months after treatment.
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)Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with painful bony metastatic disease
- Target bony metastatic lesion is painful (NRS≥4)
- Intended target region accessible for MRgHIFU treatment (usually not skull or spinal metastases above the sacrum)
- Intended target region visible on non-contrast MR imaging
Key exclusion criteria (5 listed)
- MRI contra-indicated (e.g. by incompatible metal implants, claustrophobia, or because BMI precludes accommodation in the MR scanner)
- Pregnancy
- Sedation contra-indicated
- Critical anatomical structure cannot be avoided along the beam path or the at the target (can be assessed at screening)
- Internal or external fixation device along the beam path or at the target
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)MRgHIFU treatment will be delivered using a Philips Sonalleve system, which integrates a high intensity phased array focused ultrasound transducer with our Philips 3T Achieva imaging system. An electromechanical transducer positioning system is used to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. The MR system is used to provide images to plan the therapy, and to guide and monitor the thermal ablation with thermal imaging during the treatment. | Device | MR-HIFU of painful bone metastases |
Primary outcome
Measure the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging in responders and non-responders.
Time frame: Day 30
8 secondary outcomes
To report the treatment response rate.
Time frame: up to 90 days
To investigate whether ablated tissue volume indicated by Gd-T1W imaging at Day 30 remains stable at Days 60 and 90.
Time frame: up to 90 days
.To investigate whether intra-procedural PRFS metrics are different in responders and non-responders at Day 30
Time frame: 30 days post treatment
To investigate whether intra- or post-procedural changes in ADC are different in responders and non-responders.
Time frame: Day 30
To investigate whether intra- or post-procedural changes in T2 are different in responders and non-responders.
Time frame: Day 30
The rate of treatment-related adverse events
Time frame: up to 3 months after treatment.
The effect of MRgHIFU treatment on patients' quality of life, recorded using Quality of Life Questionnaires (QLQ's).
Time frame: up to 3 months after treatment.
The costs of MRgHIFU treatment.
Time frame: up to 3 months after treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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
Institute of Cancer Research, United Kingdom
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Oct 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging in responders and non-responders. (time frame: Day 30). 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 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.