A study of high intensity focal ultrasound (HIFU) for symptoms of women’s cancers (HIFU GYNAE)

Cancer type:

Cervical cancer
Ovarian cancer
Vaginal cancer
Vulval cancer
Womb (uterine or endometrial) cancer

Status:

Open

Phase:

Pilot

This study is looking at whether high intensity focused ultrasound (HIFU) is a useful treatment for symptoms of women’s cancer such as pain and bleeding.

It is for women whose cancer has come back. Women’s cancers (gynaecological cancers) include:

  • womb cancer
  • cervical cancer
  • vulval cancer
  • vaginal cancer

More about this trial

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.

We know from research that HIFU can treat benign Open a glossary item tumours in the pelvis. These are called fibroids. It can also help with pain when cancer has spread to the bone.

In this study, researchers want to see if HIFU can help with symptoms of women’s cancer that include pain and bleeding. In some cases, you might have radiotherapy or chemotherapy to treat these symptoms. But this isn’t always possible or it doesn’t work.

The study is in 2 parts. Part 1 looked at having an MRI scan to see if it was possible to have HIFU. This part of the study is now closed. Part 2 is open and involves having an MRI scan to guide the HIFU to the tumour.

The aim of the study is to see how well MRI guided HIFU helps control symptoms of women’s cancer that has come back.

Please note – there might not be any direct benefit if you join the study. But it might help other women with troublesome symptoms of women’s cancer in the future.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join the study if the following apply.
You:

  • you have a women’s cancer that has come back after treatment
  • have cancer that the doctor can see on a scan
  • have a tumour that is painful or bleeding and isn’t suitable for other treatment
  • are suitable to have HIFU
  • have a tumour that is at least 1 cm away from the skin

Who can’t take part
You cannot join this study if any of these apply.
You:

  • can’t have an MRI scan for any reason
  • can’t have medicine that makes you drowsy (sedation)
  • have a scar, scarring from radiotherapy that  the HIFU beam would need to travel through to reach the tumour or an important body part is in the path of the beam
  • have any metal plates, screws or other metal devices inside or outside the body along the beam path or near the tumour
  • are pregnant or breast feeding

Trial design

This is a small feasibility study. There are 2 parts to this study. Part 1 is closed. Researchers hope to find 15 people to join part 2.

In part 2, you have HIFU guided by an MRI scan. To begin with you have an MRI scan to check if it is possible to treat your tumour with HIFU.

When the study team have confirmed you are suitable, they will arrange for you to come back to the hospital to have HIFU.

You have a MRI scan to guide the ultrasound to the tumour. Before the treatment you will have a small tube called a cannula put into a vein in your arm. You have drugs to make you sleepy (sedation) through the cannula. And you have a contrast medium to make the MRI scan clearer. You might also have other drugs such as pain relief and possibly an anaesthetic Open a glossary item.

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.

The treatment takes about 1 to 2 hours. You have another MRI scan immediately after treatment.

It takes up to 4 hours for you to recover afterwards. You might have some pain afterwards.

Quality of life
The researchers will ask you to fill in a diary for 30 days after treatment where you record your symptoms.

Hospital visits

You have HIFU at the hospital. 1 week after treatment you have a check up and another MRI scan.

You have a follow up appointment at:

  • 1 month
  • 2 months
  • 3 months

Side effects

People who have been treated with HIFU so far have had very few side effects.

The possible minor side effects of HIFU include:

  • pain at the treated area during treatment
  • feeling or being sick
  • swelling
  • fever
  • pain from lying in an uncomfortable position on the treatment table

The possible more serious complications include:

  • burns on your skin
  • nerve damage
  • a blood clot in your leg
  • damage to your internal organs

Your doctor will keep a close eye on you and treat any of these complications straight away.

Location

Sutton

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

Prof Nandita de Souza

Supported by

Cancer Research UK
Institute of Cancer Research
The Royal Marsden NHS Foundation Trust
National Institute of Health Research (NIHR)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15467

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

A picture of Wendy

"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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