RecruitingPHASE2INTERVENTIONAL

Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases

This study is looking at an advanced type of radiation treatment for people with cancer that has spread to their liver (hepatic metastases). The research focuses on comparing two methods of Stereotactic Body Radiotherapy (SBRT). One is the standard SBRT, and the other is a newer, more precise technique called MR-guided SBRT (MRgSBRT). MR-guided SBRT uses real-time MRI scans during treatment. This allows doctors to see the tumour more clearly, even as the patient breathes, and adjust the treatment more accurately. The main goal is to find out if this improved precision can lead to better tumour control and fewer side effects for patients, especially when tumours are close to sensitive organs like the stomach or bowel.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital Heidelberg

Enrolment target

Start

12 Aug 2021

Estimated completion

31 Jan 2030

Hepatic Metastasis

What is this study about?

This study is investigating a new way of treating liver tumours that have spread from other parts of the body. These are called 'hepatic metastases'. We know that radiation therapy can be very effective for these tumours, but it can be tricky because the liver is close to other important organs like the stomach, bowel, and kidneys. If radiation hits these organs, it can cause unwanted side effects.

The current standard radiation treatment, called Stereotactic Body Radiotherapy (SBRT), is good, but it sometimes needs to use larger 'safety margins' around the tumour to make sure the whole tumour is covered, even when you breathe. This can mean more healthy tissue gets a dose of radiation. A newer method, called MR-guided SBRT (MRgSBRT), uses MRI scans during the actual treatment. This allows doctors to see the tumour much more clearly, in real time, and adjust the radiation beam more precisely, even as the patient breathes. This precision might mean doctors can use smaller safety margins, treating only the tumour and reducing harm to nearby healthy organs, potentially allowing for stronger, more effective radiation doses.

So, this study wants to find out if this MRI-guided approach is better than the standard SBRT. The researchers hope that MRgSBRT could lead to better control of the tumours and fewer side effects for patients. They are also testing if this new method could allow them to safely deliver a higher dose of radiation to the tumour, which could make the treatment even more effective.

Key takeaways

This study compares standard radiation with a new MRI-guided radiation for liver tumours.
The new MRI-guided method aims for more precise treatment and fewer side effects.
It's for people with 1-3 liver tumours that have spread from other solid cancers.
You might be randomly assigned to receive either the standard or the new treatment.
The research hopes to find a more effective and safer way to treat these liver tumours.

Who may be eligible?

To join this study, you would need to have between one and three liver tumours (metastases) which have spread from another type of solid cancer (not leukaemia or lymphoma, for example). These tumours must be visible on an MRI scan, with no single tumour larger than 5cm, and if you have three tumours, their total size shouldn't be more than 12cm across. You also need to be at least 18 years old and generally well enough to manage the treatment, meaning you can lie still for about an hour and hold your breath for more than 25 seconds if needed.

There are also some reasons why you might not be able to join. For example, if you have primary liver cancer (which started in the liver) rather than cancer that spread there, or if you've had a liver transplant. You also wouldn't be able to take part if you have a current liver infection, claustrophobia, or if you're pregnant or breastfeeding. Certain medical devices (like some pacemakers) or allergies to MRI contrast dyes could also prevent you from participating, as they make MRI scans unsafe.

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.

Do you have 1-3 tumours in your liver that have spread from another solid cancer?
Is each liver tumour 5cm or less (and total size 12cm or less for three tumours)?
Are you 18 years old or older?
Are you able to lie still for about an hour and hold your breath for more than 25 seconds?
Have you *not* had a liver transplant or a current liver infection?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation would involve being assigned by chance to one of two or three treatment groups (like tossing a coin). Some participants will receive the standard SBRT, while others will receive the newer MR-guided SBRT. If your tumour cannot be safely treated with a high enough dose using the standard SBRT planning, you might be assigned to receive MR-guided SBRT at the highest possible dose. You will have regular appointments and scans as part of your treatment and follow-up. The exact number of visits and follow-up period will be explained to you by the study team, but generally, clinical trials involve ongoing monitoring to check how well the treatment is working and to watch for any side effects.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment approach that could be more precise and effective, possibly leading to better tumour control and fewer side effects compared to standard care. However, as with any medical treatment, there are potential risks, including side effects from the radiation therapy, which the study aims to reduce but may still occur. The new MR-guided treatment is also more complex and takes longer than standard SBRT. You will be closely monitored throughout the study, and your safety is the top priority. Remember, participating in a trial is always voluntary, and you have the right to withdraw at any time, for any reason, without affecting your usual medical care.

Locations (1)

University Hospital of Heidelberg, Radiation Oncology
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What are 'hepatic metastases'?

These are cancer tumours that have spread to your liver from cancer that started somewhere else in your body.

What is SBRT?

SBRT is a type of radiation treatment that delivers a very high dose of radiation directly to a tumour with great accuracy.

How is MR-guided SBRT different?

It uses real-time MRI scans during the radiation treatment to see the tumour more clearly, even when you breathe, allowing for more precise targeting and potentially less damage to healthy tissue.

Who is funding this research?

The information provided does not specify the funding source for this trial.

What 'phase' is this study?

This is a Phase II study, which means it's looking closely at whether the new treatment works and is safe, following earlier safety tests.

How to find out more

Jakob Liermann, PD Dr

jakob.liermann@med.uni-heidelberg.de +496221 56 Official trial record

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