Active not recruitingNAINTERVENTIONAL

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK)

This research is investigating a new treatment called the HistoSonics System for liver tumours. This system uses a special method called 'histotripsy' to treat both primary liver cancer (hepatocellular carcinoma) and cancer that has spread to the liver from other parts of the body (liver metastases). Doctors want to understand how well this treatment works and ensure it's safe for patients. It's a single-group study, meaning everyone in the trial will receive the HistoSonics treatment. Participants will be closely monitored for 30 days after the procedure, with further check-ups at 6 months and then annually for up to five years to track their progress and health.

At a glance

Status

Active not recruiting

Phase

Sponsor

HistoSonics, Inc.

Enrolment target

Start

04 Jun 2021

Estimated completion

01 Aug 2027

Liver Neoplasms Hepatocellular Carcinoma Liver Metastases

What is this study about?

This study is exploring a new way to treat liver tumours, which are abnormal growths in the liver. These tumours can either start in the liver itself (called primary liver cancer, or hepatocellular carcinoma) or spread to the liver from cancer in another part of the body (called liver metastases). The new approach involves a device called the HistoSonics System, which uses a technology called 'histotripsy'. This method aims to target and treat the liver tumours.

The main goal of this research is to see how safe and effective the HistoSonics System is for patients with these types of liver tumours. Safety means checking for any unwanted side effects or problems caused by the treatment. Effectiveness means seeing how well the treatment works to shrink or control the tumours. This is important because doctors are always looking for better and less invasive ways to treat cancer.

By taking part, patients will receive this new treatment, and doctors will carefully observe their health and the progress of their liver tumours over an extended period. This will help gather important information that could potentially benefit many other patients with liver cancer in the future, offering a new treatment option where others may not have been successful or tolerated.

Key takeaways

This study is testing a new 'histotripsy' treatment for liver tumours.
It's for people with primary liver cancer or cancer that has spread to the liver.
You must have tried other treatments that weren't successful or tolerated.
Participation involves a procedure and follow-up appointments for up to five years.
The study aims to check how safe and effective this new treatment is.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with either primary liver cancer (hepatocellular carcinoma) or cancer that has spread to your liver from another part of your body (liver metastases). For those with liver metastases, your doctors will need to confirm the cancer type and that the liver tumours are new or growing and haven't been treated yet. You'll also need to be able to have a general anaesthetic for the procedure.

There are also some health requirements. Your liver, kidney, and blood tests need to be within certain ranges, and your overall health, as assessed by your doctor, should be good enough to participate. This usually means you lead a fairly active life without severe limitations due to illness. Importantly, you should have already tried other available treatments for your cancer, such as chemotherapy or other local treatments, and these haven't worked well, or you couldn't tolerate them.

Before you can join, you'll need to fully understand the study and sign a consent form, showing you're happy to take part and attend all the required follow-up appointments. Your medical team will go through all these details with you carefully.

Quick self-check

Are you 18 years old or older?
Do you have primary liver cancer or cancer that has spread to your liver?
Have you already tried other cancer treatments that didn't work for you or caused too many side effects?
Are your liver, kidney, and blood tests within the expected range for the study?
Can you have a general anaesthetic?
Are you willing and able to attend all follow-up appointments for up to 5 years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the process will involve several key steps. First, you'll have a procedure where the HistoSonics System is used to treat your liver tumour(s). This will happen under general anaesthesia. Very soon after, within 36 hours, you'll have imaging scans (like an ultrasound or MRI) to check how successful the treatment was.

After the initial treatment, you'll be closely monitored for 30 days. This means regular check-ups to ensure you're recovering well and to look for any immediate effects of the treatment. Beyond this first month, you'll have follow-up appointments at 6 months, and then once a year for up to five years. These annual visits will involve further checks and scans to track your long-term health and the progress of your liver tumours. The total duration of your involvement in the study could be up to five years.

Potential risks and benefits

Participating in this study might offer the potential benefit of trying a new and different treatment for your liver tumours, especially if other treatments haven't been successful or suitable for you. However, as with any medical procedure, there are potential risks, including side effects from the treatment or general anaesthesia. The research team will carefully explain all known risks. You have the right to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (6)

Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
Universitätsklinikum Magdeburg Klinik für Radiologie und Nuklearmedizin
Magdeburg, Germany
Istituto Clinico Humanitas - Humanitas Mirasole S.P.A.
Milan, Italy
Vall d'Hebron
Barcelona, Spain
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom

Common questions

What is the HistoSonics System?

It's a new medical device that uses a special technology called 'histotripsy' to treat tumours in the liver.

What kind of liver cancer does this study focus on?

It's for people with primary liver cancer (hepatocellular carcinoma) or cancer that has spread to the liver from elsewhere in the body (liver metastases).

How long will I be involved in the study?

You'll be closely monitored for 30 days, then have check-ups at 6 months, and annually for up to five years.

Will I receive other treatments during the study?

This study focuses on the HistoSonics System. You should have already tried other available treatments that were not effective or tolerated.

Is this treatment available to everyone?

No, it's currently part of a clinical trial, meaning it's not yet widely available and you need to meet specific health and treatment history requirements to join.