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Sound waves vs. bone pain: can ultrasound replace radiation?

NCT ID NCT04307914

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • CSSP

    Roma, Italy

  • IOR

    Bologna, Italy

  • Isala Klinieken Zwolle

    Zwolle, Netherlands

  • TUCH Turku

    Turku, Finland

  • University Hospital Cologne

    Cologne, Germany

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3508GA, Netherlands

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