Active not recruitingNAINTERVENTIONAL

Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer

This study is about a new way to treat locally advanced non-small cell lung cancer (LA-NSCLC) using radiation. This type of cancer is common and often hard to treat effectively. The new method, called MR-guided adaptive radiotherapy, uses MRI scans to precisely guide the radiation treatment. The goal is to make the treatment more accurate by adjusting it in real-time to changes in the tumour and surrounding healthy organs. This could mean fewer side effects and potentially better control of the cancer. This initial study aims to show that this new method is practical and safe for patients with LA-NSCLC, paving the way for further research to compare it with current treatments.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

Start

23 Jun 2022

Estimated completion

01 Mar 2028

Non-small Cell Lung Cancer

What is this study about?

Lung cancer, specifically non-small cell lung cancer (NSCLC), is a very serious illness. For people with locally advanced NSCLC, where the cancer has grown but hasn't spread widely, treatment can be challenging. Standard treatments often include a combination of chemotherapy and radiation therapy. While these treatments are vital, there's always a challenge to deliver enough radiation to kill the cancer cells without harming nearby healthy organs, such as the lungs and heart.

This study explores an exciting new approach called MR-guided adaptive radiotherapy. Think of it like this: traditional radiation therapy often uses CT scans taken before treatment to plan where the radiation goes. However, your body and the tumour can shift slightly between appointments. This new method uses MRI scans *during* the treatment itself. This means the medical team can see the tumour and surrounding organs very clearly, and if anything has moved, they can adjust the radiation plan right there and then. This personalised approach aims to make the treatment much more precise.

The main goal of this particular study, called PUMA, is to see if this MR-guided adaptive radiotherapy is practical and safe for people with locally advanced NSCLC. If this initial study shows good results, it will help researchers design larger studies to find out if this new method is better than current treatments in controlling the cancer and reducing side effects. Ultimately, the hope is to improve the outlook and quality of life for patients with this type of lung cancer by making radiation treatment more effective and gentler on the body.

Key takeaways

Exploring a new, more precise way to deliver radiation for locally advanced lung cancer.
Uses MRI scans to guide radiation, aiming for better tumour targeting.
Could potentially lead to fewer side effects and improved cancer control.
This is an early study to check if the new method is practical and safe.
May require you to lie still for longer periods during treatment compared to standard radiation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you would need to have non-small cell lung cancer that is considered 'locally advanced' – meaning it's grown within your chest area but hasn't spread further. You would also need to be aged 18 or over and generally well enough to undergo standard chemotherapy and radiation therapy. Doctors would check your lung function to make sure it's adequate, and you'd need to be able to lie still on an MRI machine for about an hour and hold your breath for at least 20 seconds. It's also important that you understand what the study involves and are happy to give your written consent to participate.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread to certain lymph nodes above your collarbone, or if you have additional cancer spots in your lungs. If you've had radiation to your lung area before and it overlaps with the new treatment area, you might not be suitable. Also, if you have certain medical devices like pacemakers that make MRI scans unsafe, or if you are pregnant or breastfeeding, you wouldn't be able to take part.

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 locally advanced non-small cell lung cancer?
Are you 18 years old or older?
Are you able to lie still on an MRI machine for about an hour?
Are you able to hold your breath for at least 20 seconds?
Do you have good enough lung function for standard lung cancer therapy?
Do you have any implants (like a pacemaker) that might prevent you from having an MRI scan?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive radiation therapy for your lung cancer, but it will be guided by MRI scans. This means that instead of traditional radiation machines, you'll be treated using a special machine that combines an MRI scanner with a radiation delivery system. Each treatment session will involve lying on the machine, and the team will use MRI to check your position and the tumour's location before and possibly during treatment, adjusting the plan as needed. The study does not mention specific extra visits beyond your normal treatment schedule, but MRI-guided radiation takes longer than standard radiation. The main difference is the technology used for your treatment and the detailed planning involved.

While the detailed duration isn't specified, radiation therapy for lung cancer typically takes several weeks. You will be closely monitored throughout your treatment and afterwards to check how you are responding and if you experience any side effects. The total duration of follow-up for this study is not explicitly stated in the brief information provided.

Potential risks and benefits

Taking part in this study could potentially offer you a more precise radiation treatment, which in the future might lead to better control of your cancer and potentially fewer side effects on healthy organs. However, as with any new treatment, there are potential risks, some of which may be unknown. The treatment involves radiation, which always carries risks, and the MRI part might involve lying still for longer or experiencing discomfort if you are claustrophobic. Also, undergoing MRI scans with certain implants could be risky, which is why an eligibility check is vital. You are always free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (3)

Universitätsklinikum Tübingen
Verified postcode
Tübingen, Germany
Ludwig-Maximilian-Universität München
Approximate
Münich, Germany
University Hospital of Heidelberg, Radiation Oncology
Verified postcode
Heidelberg, Germany

Common questions

What is 'locally advanced non-small cell lung cancer'?

This means your lung cancer has grown into nearby tissues or lymph nodes within your chest, but it hasn't spread to distant parts of your body.

What is 'MR-guided radiotherapy'?

It's a new type of radiation treatment where MRI scans are used at the same time as radiation delivery. This helps doctors see the tumour and surrounding organs very clearly, allowing for more precise treatment and adjustments during your session.

Why is this not a standard treatment yet?

This is a new and innovative technique. This study is an 'early clinical trial' or 'feasibility study' to understand if it's practical and safe before it can be compared to current standard treatments in larger studies.

Will I still get my usual chemotherapy?

The study mentions 'definitive thoracic chemoradiotherapy,' which means it's designed for patients who would normally receive both chemotherapy and radiation. The study focuses on how the radiation part is delivered.

What if I have an implant like a pacemaker?

Certain implants, like pacemakers, can make MRI scans unsafe or impossible. If you have such an implant, you would likely not be able to join this particular study.