Bone MetastasesBM-RT-HIFUNCT05167669
Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU
A study testing HIFU-MRI guided in people with Bone Metastases and Radiotherapy, run by Sana Boudabbous at 1 site in Switzerland.
Trial summary
Metastatic disease to the bone is a common cause of pain. External beam radiation therapy (EBRT) is the standard palliative treatment BUT pain improvement is observed in 60% to 80%. Combination of hyperthermia (HT) with radiation is strongly compelling. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Bone Metastases, Radiotherapy, Pain
- What is being tested?
- HIFU-MRI guided
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2022to 1 Jan 2025
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Histologically proven cancer;
- cancer-related pain corresponding to a site (or sites) of radiologically confirmed bone metastases with a severity score of at least 2 out of 10 according to the Brief Pain Inventory (NRS scale);
- age ≥ 18 years;
- indication for a palliative course of EBRT;
- osteolytic or mixed (osteoblastic/osteolytic) bone metastases ≤ 5 cm in the largest diameter; target tumours accessibility for device (ribs, extremities, pelvis, shoulders or posterior aspects of spinal vertebra) and at least 1 cm from skin and major nerve bundles;
Who cannot join
- Inability to provide a written informed consent;
- Karnofsky performance status (KPS) < 60; presence of clinical or radiological evidence of spinal cord compression, a pathological fracture, or an impending fracture needing surgical fixation;
- previous EBRT to study site (or sites);
- participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry;
- inability to comply with study and follow up procedures;
- patients having metal implants, pacemakers or clustered markers non-MR compatible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Relief in Patients With Symptomatic Bone Metastases: a Feasibility Pilot Study on Palliative Radiotherapy With Adjuvant Hyperthermia by Magnetic Resonance-guided Focused Ultrasound
Metastatic disease to the bone is a common cause of pain. External beam radiation therapy (EBRT) is the standard palliative treatment BUT pain improvement is observed in 60% to 80%. Combination of hyperthermia (HT) with radiation is strongly compelling. MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases.
Read the detailed description
Metastatic disease to the bone is a common cause of pain and other significant symptoms with a detrimental impact into quality of life. Up to 85% of the patients dying from breast, prostate, or lung cancer present bone metastases. External beam radiation therapy (EBRT) is one of the standard palliative treatment modalities effective in palliating painful bone metastases. Using patient-based evaluation method, pain improvement is observed in 60% to 80% of the patients, with 15% to 40% complete pain relief. Combination of hyperthermia (HT) with radiation is strongly compelling as it is based on principles of classic radiobiology, molecular biology, and tumor physiology. Elevating temperature to a supra-physiological level (between 41° and 43°) shows a complementary action when combined with RT with regard to cell killing. Magnetic resonance (MR) imaging is commonly used in clinical routine for radiological diagnostic and staging. Moreover, MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases. Ex vivo studies for the adaptation of existing MR-guided focused ultrasound (MRgFUS) device were already conducted at University Hospitals of Geneva to the current application demonstrating the high accuracy of the technique for mild hyperthermia treatments. A clinical prospective, interventional, single-center pilot feasibility study will be conducted to assess the clinical application of this technique.
Primary objective
- Accurate control of spatio-temporal pixel-wise MR thermometry (several hundred pixels): spatial homogeneity of temperature elevation within the tumour and inter-patient reproducibility (expected standard deviation of 0.5°C).
- Safety and patient tolerance: no adverse effects in surrounding bone and soft tissues, compliance with one-day dual treatment during the first month.
Secondary objectives
- Complete pain response at 28 days after EBRT + HT based on the International Bone Metastases Consensus Endpoint definition.
- Pain assessment for the worst pain related to the treated lesion using the Brief Pain Inventory score at baseline, at day 1, day 7, and 28 days after treatment after EBRT + hyperthermia.
- Health-related quality of life evaluated using self-administered EORTC QLQ-C15-PAL and EORTC QLQ-BM22 (bone metastases module) questionnaires at baseline, day 7, and day 28 after EBRT + hyperthermia.
- Conditions
- Bone Metastases, Radiotherapy, Pain, MRI
- Being tested
- HIFU-MRI guided
- Keywords
- BONE METASTASES, PAIN, MRI, HIFU, RADIOTHERAPY
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU-MRI guidedDevice
HIFU application under MRI guiding to deliver hypothermia to eligible bone metastases before clinical indicated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Prospective, interventional, single-center, feasibility pilot study. | Other | 10 patients with radiologically confirmed bone metastases and eligible for a course of palliative EBRT. Eligible patients will be mainly discussed and recruited in a dedicated tumor-board for bone metastases performed in a weekly basis at HUG. Receives: Device: HIFU-MRI guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate elevation of temperature measured by MRI thermometry (degree celsius)
Accurate control of spatio-temporal pixel-wise MR thermometry (several hundred pixels): spatial homogeneity of temperature elevation within the tumour and inter-patient reproducibility (expected standard deviation of 0.5°C).
Measured: day 1
Safety and patient tolerance according to The adverse events (CTCAE v5.0) (Art. 2 Abs 58 MDR)
Safety and patient tolerance: no adverse effects in surrounding bone and soft tissues, compliance with one-day dual treatment during the first month.
Dermatitis of grade 3 or more - Pain of skin grade 3
- Skin atrophy grade 3
- Localized edema of grade 3
- Bone fracture of grade 3 or more
Measured: day 1
Secondary outcomes (4)
Complete pain response according to International Bone Metastases Consensus Endpoint score (BPI score)
Complete pain response based on the International Bone Metastases Consensus Endpoint definition.
Measured: at 28 days after EBRT + HT
Pain assessment using Brief Pain Inventory score (BPI score)
Pain assessment for the worst pain related to the treated lesion using the Brief Pain Inventory score
Measured: at day 1, day 7, and 28 days after treatment after EBRT + hyperthermia.
quality of life using EORTC QLQ-C15-PAL (bone metastases module) questionnaires.
Health-related quality of life evaluated using self-administered EORTC QLQ-C15-PAL (bone metastases module) questionnaires
Measured: day 1, day 7, and 28 days after EBRT + hyperthermia.
quality of life using EORTC QLQ-BM22 (bone metastases module) questionnaires.
Health-related quality of life evaluated using self-administered EORTC QLQ-BM22 (bone metastases module) questionnaires
Measured: day 7, and day 28 after EBRT + hyperthermia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Oct 2022
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
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.
- 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
- Model description
- Number of participants: 10 patients with radiologically confirmed bone metastases and eligible for a course of palliative EBRT. Eligible patients will be mainly discussed and recruited in a dedicated tumor-board for bone metastases performed in a weekly basis at HUG.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Boudabbous
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sana Boudabbous, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167669
- Sponsor's protocol ID
- 2020-02998
- Acronym
- BM-RT-HIFU
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief in Patients With Symptomatic Bone Metastases: a Feasibility Pilot Study on Palliative Radiotherapy With Adjuvant Hyperthermia by Magnetic Resonance-guided Focused Ultrasound
- ClinicalTrials.gov ID
- NCT05167669
- Acronym / sponsor ID
- BM-RT-HIFU / 2020-02998
- Conditions
- Bone Metastases, Radiotherapy, Pain, MRI
- Keywords
- BONE METASTASES, PAIN, MRI, HIFU, RADIOTHERAPY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sana BoudabbousUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 22 Dec 2021 (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.
Metastatic disease to the bone is a common cause of pain. External beam radiation therapy (EBRT) is the standard palliative treatment BUT pain improvement is observed in 60% to 80%. Combination of hyperthermia (HT) with radiation is strongly compelling. MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases.
Detailed description
Metastatic disease to the bone is a common cause of pain and other significant symptoms with a detrimental impact into quality of life. Up to 85% of the patients dying from breast, prostate, or lung cancer present bone metastases. External beam radiation therapy (EBRT) is one of the standard palliative treatment modalities effective in palliating painful bone metastases. Using patient-based evaluation method, pain improvement is observed in 60% to 80% of the patients, with 15% to 40% complete pain relief. Combination of hyperthermia (HT) with radiation is strongly compelling as it is based on principles of classic radiobiology, molecular biology, and tumor physiology. Elevating temperature to a supra-physiological level (between 41° and 43°) shows a complementary action when combined with RT with regard to cell killing. Magnetic resonance (MR) imaging is commonly used in clinical routine for radiological diagnostic and staging. Moreover, MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases. Ex vivo studies for the adaptation of existing MR-guided focused ultrasound (MRgFUS) device were already conducted at University Hospitals of Geneva to the current application demonstrating the high accuracy of the technique for mild hyperthermia treatments. A clinical prospective, interventional, single-center pilot feasibility study will be conducted to assess the clinical application of this technique.
Primary objective
- Accurate control of spatio-temporal pixel-wise MR thermometry (several hundred pixels): spatial homogeneity of temperature elevation within the tumour and inter-patient reproducibility (expected standard deviation of 0.5°C).
- Safety and patient tolerance: no adverse effects in surrounding bone and soft tissues, compliance with one-day dual treatment during the first month.
Secondary objectives
- Complete pain response at 28 days after EBRT + HT based on the International Bone Metastases Consensus Endpoint definition.
- Pain assessment for the worst pain related to the treated lesion using the Brief Pain Inventory score at baseline, at day 1, day 7, and 28 days after treatment after EBRT + hyperthermia.
- Health-related quality of life evaluated using self-administered EORTC QLQ-C15-PAL and EORTC QLQ-BM22 (bone metastases module) questionnaires at baseline, day 7, and day 28 after EBRT + hyperthermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Number of participants: 10 patients with radiologically confirmed bone metastases and eligible for a course of palliative EBRT. Eligible patients will be mainly discussed and recruited in a dedicated tumor-board for bone metastases performed in a weekly basis at HUG.
| Arm | Type | Receives |
|---|---|---|
| Prospective, interventional, single-center, feasibility pilot study. | Other | Device: HIFU-MRI guided10 patients with radiologically confirmed bone metastases and eligible for a course of palliative EBRT. Eligible patients will be mainly discussed and recruited in a dedicated tumor-board for bone metastases performed in a weekly basis at HUG. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- • Histologically proven cancer;
Key exclusion criteria (6 listed)
- Inability to provide a written informed consent;
- Karnofsky performance status (KPS) < 60; presence of clinical or radiological evidence of spinal cord compression, a pathological fracture, or an impending fracture needing surgical fixation;
- previous EBRT to study site (or sites);
- participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry;
- inability to comply with study and follow up procedures;
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 |
|---|---|---|
| HIFU-MRI guidedHIFU application under MRI guiding to deliver hypothermia to eligible bone metastases before clinical indicated radiotherapy | Device | Prospective, interventional, single-center, feasibility pilot study. |
Primary outcome
Accurate elevation of temperature measured by MRI thermometry (degree celsius)
Time frame: day 1
Accurate control of spatio-temporal pixel-wise MR thermometry (several hundred pixels): spatial homogeneity of temperature elevation within the tumour and inter-patient reproducibility (expected standard deviation of 0.5°C).
Safety and patient tolerance according to The adverse events (CTCAE v5.0) (Art. 2 Abs 58 MDR)
Time frame: day 1
Safety and patient tolerance: no adverse effects in surrounding bone and soft tissues, compliance with one-day dual treatment during the first month. Dermatitis of grade 3 or more - Pain of skin grade 3 * Skin atrophy grade 3 * Localized edema of grade 3 * Bone fracture of grade 3 or more
4 secondary outcomes
Complete pain response according to International Bone Metastases Consensus Endpoint score (BPI score)
Time frame: at 28 days after EBRT + HT
Pain assessment using Brief Pain Inventory score (BPI score)
Time frame: at day 1, day 7, and 28 days after treatment after EBRT + hyperthermia.
quality of life using EORTC QLQ-C15-PAL (bone metastases module) questionnaires.
Time frame: day 1, day 7, and 28 days after EBRT + hyperthermia.
quality of life using EORTC QLQ-BM22 (bone metastases module) questionnaires.
Time frame: day 7, and day 28 after EBRT + hyperthermia.
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 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU-MRI guided in people with Bone Metastases and Radiotherapy, run by Sana Boudabbous at 1 site in Switzerland.
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 5 inclusion and 6 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 2 Apr 2025. 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 Switzerland. 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?
Accurate elevation of temperature measured by MRI thermometry (degree celsius) (time frame: day 1). The study lists 2 primary outcomes in all. 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 2 Apr 2025.