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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Functional lung avoidance planning guided by lung perfusion PET/CT versus anatomical planning for lung stereotactic body radiotherapy: a double blinded, randomized, controlled trial

This study is looking at whether a new way of planning radiation treatment for lung cancer can reduce side effects. Patients in the study have primary or secondary lung tumours and are already planning to have a treatment called SBRT, which is a type of radiotherapy. The new planning method uses a special scan called a lung perfusion PET/CT. Researchers want to see if this method leads to fewer lung side effects, like breathing difficulties, compared to the usual planning method. They will look at whether people experience fewer lung problems in the year after their treatment. The study will also check quality of life, how well the treatment controls the tumour, and overall survival.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Centre Hospitalier Regional Et Universitaire De Brest
Enrolment target
418
Start
07 Oct 2025

What is this study about?

This clinical trial is designed for people who have lung cancer, either a primary tumour that started in the lung or a secondary tumour that spread to the lung, and are scheduled to have a specific type of radiation treatment called SBRT (Stereotactic Body Radiotherapy). SBRT is a powerful and very focused form of radiation.

The main goal of this study is to compare two different ways of planning this radiation treatment. One way is the standard method, which plans the treatment based on the shape and size of the tumour. The other method uses a special scan called a lung perfusion PET/CT. This scan helps doctors see which parts of your lungs are working best, allowing them to plan the radiation to avoid those healthy, working areas as much as possible. The hope is that by avoiding these areas, patients might have fewer side effects, especially to their lungs.

The researchers want to find out if planning treatment using this special scan leads to fewer lung problems, like inflammation or difficulty breathing, within the year after SBRT. They will also be looking at overall well-being, how the tumour responds to treatment, and how long people live after their treatment. This information will help doctors choose the best and safest way to treat lung cancer in the future.

Key takeaways

  • This study compares two ways to plan lung radiation treatment.
  • It aims to reduce lung-related side effects after SBRT for lung cancer.
  • A special scan may help doctors avoid healthy lung tissue during planning.
  • Your health and quality of life will be checked for one year.
  • Both primary and secondary lung tumour patients having SBRT can take part.

Who may be eligible?

You might be able to take part in this study if you are an adult, aged 18 or over. This study includes both men and women.

The most important thing is that you have a primary (started in the lung) or secondary (spread to the lung) lung tumour and your doctors have already decided that you will be treated with a powerful type of radiation called SBRT (Stereotactic Body Radiotherapy).

There might be other specific health requirements or conditions that would mean you can or cannot join the study, but these are the main points for initial consideration.

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.

  1. Are you 18 years old or older?
  2. Do you have a primary or secondary lung tumour?
  3. Are your doctors planning for you to have SBRT (Stereotactic Body Radiotherapy)?
  4. Are you able to attend follow-up appointments for about a year?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your SBRT treatment planned using either the standard method or the newer method involving a special scan. You won't know which planning method you receive, and neither will your doctors who check for side effects. You will receive a small, safe injection of a substance called [68Ga]Ga-MAA for the special scan if you are in that group.

After your SBRT treatment, doctors will keep a close eye on your health, especially your lungs, for a full year. You will answer questionnaires about your quality of life at 3, 6, 9, and 12 months after treatment. These appointments will involve check-ups to assess any lung side effects. There will also be follow-up scans or tests to check on your tumour's response and any changes in your lungs, particularly a lung perfusion PET/CT at 3 months if you are in the special scan group. The total duration of active follow-up for this study is one year.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of receiving a new or different approach to your treatment planning that aims to reduce side effects. However, there is no guarantee that you will personally benefit. As with any medical procedure, there are potential risks, including side effects from the special scan substance, though this is considered very safe. Your health will be carefully monitored throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is SBRT?

SBRT is a special type of very focused radiation treatment that delivers high doses to a small area, like a tumour, while trying to protect surrounding healthy tissue.

What is the new scan, a lung perfusion PET/CT?

This is a type of scan that helps doctors see which parts of your lungs are working best. The idea is to direct radiation away from these active parts to reduce side effects.

Will I know which treatment planning method I get?

No, you won't know which planning method you receive, and the doctors checking for side effects won't know either. This helps make the study as fair as possible.

What kind of lung problems are they looking for?

The study is looking for side effects to the lungs, such as inflammation or difficulty breathing, that might happen after radiation treatment.

How long will I be followed up if I join?

You will be followed up for one year after your radiation treatment to check your health and how you are feeling.

How to find out more

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

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