A study looking at high intensity focused ultrasound to treat pain from cancer spread to the bones

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Other

This study is looking at whether high intensity focused ultrasound (HIFU) is a useful treatment for pain from cancer that has spread to the bones. HIFU is the use of high frequency sound waves. These waves deliver a strong beam to a specific part of a cancer. Some cells die when this high intensity ultrasound beam is focused directly onto them. In this study, the HIFU will be guided to the cancer in the bone by MRI scanning.

More about this trial

Cancer that spreads to the bone is also called bone metastases or secondary bone cancer.  It often causes pain. Doctors usually treat the pain with painkillers and radiotherapy.  In this study the researchers are looking at giving HIFU guided by MRI using the Philips Sonalleve MR-HIFU system. They want to see how useful HIFU is for helping bone pain. They also want to see if the treatment causes any side effects and how the treatment affects your day to day life.

Who can enter

You may be able to join this study if all of the following apply. You

  • Have been diagnosed with secondary cancer in the bones  and have one area that is very painful
  • Have been on painkillers that are helping you for at least 1 week
  • Have cancer in your bones that can be seen by MRI scan without using a contrast medium Open a glossary item
  • Have not had any other local treatment Open a glossary item such as radiotherapy to the area the doctors want to treat with HIFU in the last 4 weeks
  • Are able to tell the doctors what you are feeling during treatment
  • Weigh less than 140kg (22 stone)
  • Are at least 18 years old

You cannot join this study if any of these apply. You

  • Have cancer that started in the bones
  • Have a lymphoma or leukaemia or a type of cancer called myeloma
  • Are unable to have an MRI scan
  • Are unable to have contrast medium
  • Are unable to have sedation Open a glossary item
  • Are unable to remain still during treatment
  • Have pain due to a broken bone (fracture Open a glossary item) or pain from a bone that could break (potential fracture)
  • Have bone pain related to cancer pressing on a nerve, such as spinal cord compression (your doctors can advise you about this)
  • Need to have surgery for a broken bone or because your doctor thinks there is a high risk of the bone breaking
  • Have a metal pin or plate in your bone
  • Have had surgery to the place where the doctors plan to treat the bone pain
  • Have a scar in the place where the doctors plan to treat the bone pain
  • Have cancer in a bone that the doctors think is too close to your skin, bladder, bowel, major internal organs or any major nerves
  • Have secondary bone cancer causing you pain if it is in your skull, joints, ribs (close to your lungs), spine (except the lower part of your spine called your sacrum) or your breast bone (sternum)
  • Are already taking part in another clinical trial or study looking at a way of treating or managing pain  in your bones
  • Have any medical condition that the study team think could affect you taking part
  • Are pregnant

Trial design

This is an international study. The researchers want about 54 people to take part.

Everybody taking part will have HIFU guided by an MRI scan. The scan is used to guide the ultrasound towards the cancer in your bone. The ultrasound then directs sound waves towards the cancer. This generates heat that destroys the cancer cells. When the HIFU treatment is finished you will have another MRI scan.

Before the treatment you will have a small tube called a cannula put into a vein in your arm. This will be used to give you drugs to make you sleepy (sedation), as well as a contrast medium which is used to make the MRI scan clearer. It may also be used to give you other drugs such as additional pain relief and possibly an anaesthetic Open a glossary item.

If necessary, the area where the HIFU will be given will be shaved.  The treatment and recovery time afterwards will take up to 4 hours.

The researchers will ask you to complete some questionnaires before you have treatment, the day after your treatment and then at various times during the following 90 days. The questionnaires will ask you about your pain, any side effects you have and how you are feeling. They are called quality of life questionnaires.

The researchers will also give you a diary and ask you to write down details of your pain level and use of painkillers. They will ask you to complete this for 30 days after you have the HIFU.

Hospital visits

You see the study doctor and have some tests before having treatment. The tests include

You will need to go to hospital for the HIFU treatment. You should not need to stay overnight.

You will need to go back to the hospital to see the doctors 1, 2, and 3 months after you have treatment. They will examine you and you will have an X-ray or CT scan and an MRI scan.

Side effects

Some of the known side effects of HIFU include

  • Pain (this is temporary)
  • Feeling and being sick
  • Swelling at the place where the HIFU is directed
  • High temperature (fever)
  • Discomfort from lying in 1 position

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Nandita de Souza

Supported by

Institute of Cancer Research (ICR)
NIHR Clinical Research Facility
Philips Medical Systems MR Finland

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12809

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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