CompletedNot ApplicableInterventional

Testing if the SonoTran Platform can enhance drug delivery in metastatic colorectal cancer

Bowel cancer is one of the most common cancers in the UK. When it spreads to the liver, it can become difficult to treat because medicines struggle to reach deep inside the tumours. This early study, led by the University of Oxford, is testing an approach called the SonoTran Platform. The system combines tiny particles given through a drip with a specialist ultrasound scan applied to the skin over the liver. Scientists hope the ultrasound waves will activate the particles to gently push cancer drugs further into the tumours. The trial is divided into three small groups. These test safety, check how deeply the medicines penetrate tumour tissue, and compare tumour shrinkage when SonoTran is added to regular chemotherapy. Taking part involves hospital visits, scans, and blood tests to monitor your health and see how well the technology works.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Oxford

Enrolment target

Start

31 Oct 2021

Estimated completion

30 Aug 2024

Colorectal cancer liver metastases (CRLM)

What is this study about?

When bowel cancer spreads to other organs, it most often travels to the liver. Doctors have effective medicines to help control the disease, including chemotherapy and targeted antibody treatments. However, liver tumours often have poor blood flow and tough surrounding tissue. This makes it hard for cancer drugs to travel deep inside them to do their job.

The SonoTran Platform is an experimental technique designed to tackle this problem. It uses two parts working together. First, tiny cup-shaped particles are given through a standard drip into your vein. Second, a doctor or nurse places a specialist ultrasound probe on the skin over your liver. When the soundwaves hit the particles inside the liver tumours, they create gentle microscopic movements that help push the cancer medicines deeper into the cancer cells.

This trial is divided into three groups of patients. The first group tests the safety of the ultrasound and particles on their own. The second group tests the system in patients already booked for liver surgery, allowing doctors to measure drug levels in the removed tissue. The third group tests whether adding SonoTran to standard chemotherapy helps shrink tumours better than chemotherapy alone.

Because this is the first time the SonoTran Platform has been tested in humans, the main goal is to find out if it is safe and practical. If successful, this research could pave the way for more effective cancer treatments in the future without needing higher doses of chemotherapy.

Key takeaways

The CEeDD trial is testing a new ultrasound-based method to help cancer drugs reach deeper into liver tumours.
It is designed for adults with bowel cancer that has spread to the liver.
The technology uses microscopic particles through a drip combined with a gentle ultrasound over the liver.
This is a first-in-human study running through the University of Oxford to test safety and performance.
Taking part is completely voluntary and will not delay any planned surgery you may have booked.

Who may be eligible?

This study is open to adults aged 18 and over who have bowel cancer that has spread to the liver. To take part, your liver tumours must be in a position where the ultrasound device can safely reach them through the skin. You will also need to have reasonable general health, good kidney and liver function, and satisfactory blood counts.

Which part of the study you might join depends on your current treatment stage. You may be eligible for the safety group if you have finished standard treatments or are on a treatment break. You might join the second group if you are already scheduled to have your liver tumours surgically removed. The third group is for people who are about to start standard chemotherapy for liver spread.

You cannot take part if you are pregnant, if your liver tumours are out of reach of the ultrasound probe, or if your blood tests show that your body cannot safely handle the study procedures. Your doctor or cancer specialist will review your medical history and scans to check if this trial is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or over.
I have been diagnosed with bowel cancer that has spread to my liver.
I have at least one liver tumour measuring more than 1 centimetre across.
I am either due for liver surgery, taking a treatment break, or about to start chemotherapy.
I am well enough to attend hospital visits for scans, blood tests, and check-ups.

Answer every question to see your result.

What does participation involve?

What taking part involves depends on which group you join. If you are in the first or second group, you will receive a single treatment with the SonoTran particles and ultrasound, followed by regular check-ups once a week for about a month. If you are in the second group, your planned liver surgery will go ahead the day after your study treatment without delay.

If you join the third group, you will receive standard chemotherapy every two weeks for ten weeks (six cycles in total). Half of the patients in this group will also receive the SonoTran ultrasound and particle treatment alongside their chemotherapy.

Throughout the study, you will have regular hospital visits for physical checks (such as blood pressure, pulse, and temperature), routine blood tests, and imaging scans (including CT, MRI, or PET scans). These scans allow the team to monitor your safety and check how your tumours respond. Blood samples are also collected before and after the treatments to see how the body handles the particles.

Potential risks and benefits

If you join the first or second group, there is no direct medical benefit to you, as you will not receive full-dose cancer treatment as part of the study; however, your participation helps doctors learn how to improve treatments for others. If you join the third group, you will receive standard cancer treatment, and the new platform might help the drugs work better, though this cannot be promised. Because this is the first time SonoTran has been used in people, there may be unexpected side effects. Known possible risks include mild irritation to the vein where the drip enters and temporary liver inflammation. If you receive chemotherapy, you may experience common side effects such as nausea, tiredness, hair thinning, and a higher risk of infections. Taking part is entirely voluntary, and you are free to leave the trial at any point without it affecting your standard NHS care.

Locations (2)

Churchill Hospital
Approximate
Oxford, England
Queen Elizabeth Hospital
Approximate
Birmingham, England

Common questions

Will taking part delay my planned liver surgery?

No. If you are in the surgical group, the study treatment is given the day before your operation. Your surgery will proceed as normal with your regular surgical team.

Does the SonoTran ultrasound treatment hurt?

The ultrasound probe rests on the skin over your liver with a layer of gel, very much like a standard ultrasound scan, and should not be painful.

Will I have to pay to take part?

No. All study treatments, tests, and extra scans are covered by the trial funders, which include the National Institute for Health and Care Research (NIHR) and OxSonics Ltd.

Can I leave the study if I change my mind?

Yes. You can withdraw from the study at any time, for any reason. Your regular doctors will continue to provide your usual NHS cancer care.

Is this a cure for bowel cancer?

No. This is an early-stage clinical trial designed to find out if this new device is safe and whether it helps deliver cancer medicines deeper into tumours.

How to find out more

Lynda Swan

octo-ceedd@oncology.ox.ac.uk +44 (0)1865 617085 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.