Sound waves vs. bone pain: can ultrasound replace radiation?
NCT ID NCT04307914
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether MR-guided focused ultrasound (MR-HIFU), alone or with standard radiotherapy, can better relieve pain from bone metastases than radiotherapy alone. About 216 adults with painful bone lesions will be randomly assigned to one of three groups. The goal is to see if this non-invasive heat treatment can improve pain response and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MR-guided high-intensity focused ultrasound (MR-HIFU)
- What this could lead to
- If it works, this could offer a non-invasive, drug-free option to reduce severe bone pain from cancer that has spread, improving quality of life without surgery.
- What could go wrong
- This is a mid-stage trial, not yet proven in large populations. The ultrasound procedure may not work for all tumor locations, and pain relief may vary. Risks include tissue heating or nerve damage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient capable of giving informed consent * Age ≥ 18 years * Painful metastatic bone lesion (NRS \> 2) * Patient-localised pain with a distinct pathological substrate on recent CT/MRI * Target lesion location is sufficiently accessible for MR-HIFU to expect clinical response, as judged by the (intervention) radiologist * Participant has a reasonable performance score (KPS ≥ 50% or Zubrod/ECOG/WHO \< 3) * Life expectancy ≥ 3 months Exclusion Criteria: * Participant is not able to fit in the MR gantry * Need for surgery of targeted location due to (impending) pathological fracture * Unavoidable critical structures or dense tissues in target area * Contra-indications for MRI or sedation/anesthesia * Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician * Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment All patients meeting the FURTHER in- and exclusion criteria as described above will be included in this study, either in the FURTHER RCT or FUTHER Registry. The following inclusion criteria are used to decide upon the arm patients will participate in. If patients meet all of the following RCT inclusion criteria, they will be asked to participate in the FURTHER RCT. Alternatively, patients who do not meet one or more of these criteria will be asked to participate in the FURTHER Registry. * Painful bone lesion (NRS ≥ 4) * Indication for EBRT treatment of a bone lesion * Exclusively palliative intention of EBRT treatment plan * No previous surgery on the target location * No neurological symptoms due to nerve involvement of target lesion * No (impending) pathological fracture) * EBRT replacable by MR-HIFU based on medical history or phyiscal findings judged by multidisciplinary team * Target lesion location is completely accessible for MR-HIFU
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CSSP
Roma, Italy
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IOR
Bologna, Italy
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Isala Klinieken Zwolle
Zwolle, Netherlands
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TUCH Turku
Turku, Finland
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University Hospital Cologne
Cologne, Germany
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University Medical Center Utrecht
Utrecht, Utrecht, 3508GA, Netherlands
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