A pivotal phase 3 clinical trial to assess the diagnostic performance and safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a positron emission tomography (PET) imaging agent, versus [18F]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma (MZL) exemplary for CXCR4-positive malignant lymphomas: a prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial (LYMFOR).
This study is looking at people who have been diagnosed with marginal zone lymphoma, which is a type of cancer. It compares two different types of body scans, called PET/CT scans. One scan uses a substance called [68Ga]Ga-PentixaFor, and the other uses [18F]FDG. The main goal is to find out if the [68Ga]Ga-PentixaFor scan is better, or at least as good as, the standard [18F]FDG scan at spotting cancer cells in the body. Researchers also want to see if these scans help doctors plan the best treatment for patients and how different doctors interpret the scan results. This information will help improve how this cancer is diagnosed and managed.
At a glance
What is this study about?
This study is about a type of cancer called marginal zone lymphoma. When someone is diagnosed with cancer, doctors need to know if the cancer has spread and how much. This process is called "staging," and it helps doctors decide on the best treatment plan. Currently, a type of scan called an [18F]FDG PET/CT scan is often used for this purpose.
This study is comparing that standard [18F]FDG PET/CT scan with a newer type of scan called a [68Ga]Ga-PentixaFor PET/CT scan. Both are types of body scans that can help doctors see inside the body. The researchers want to find out if the newer [68Ga]Ga-PentixaFor scan is better or at least as good as the standard scan at finding cancer cells. They are particularly interested in seeing if it can find cancer cells more accurately.
The study will also look at how reliable each scan is, meaning whether different doctors get the same results when looking at the scans. Importantly, they want to see if the information from either scan changes how doctors decide to treat a patient. By comparing these two scans, the study hopes to improve the way marginal zone lymphoma is diagnosed and to help doctors make more informed decisions about treatment.
Key takeaways
- A study for people with marginal zone lymphoma.
- Compares two types of body scans (PET/CT) to find cancer more effectively.
- Aims to see if a newer scan is better than the standard one.
- Hopes to improve how marginal zone lymphoma is diagnosed and managed.
- Participation involves having two different diagnostic scans and follow-up.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women can take part.
Key to joining is having a confirmed diagnosis of marginal zone lymphoma. This means your doctors have already found that you have this specific type of cancer.
The study welcomes people of all ages who meet the basic requirements, but there will be specific medical checks to ensure it's safe for you to participate.
- Are you 18 years old or older?
- Have you been diagnosed with marginal zone lymphoma?
- Are you able to travel to the study site for appointments?
- Are you comfortable having two different types of body scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will have two different types of PET/CT body scans. These scans will be done at different times, in no particular order. You will also have follow-up appointments where doctors will check your progress and review your medical information and scan results. The exact number of visits and the total length of your participation will be explained in detail by the study team, but it includes the scans and ongoing monitoring of your condition.
Potential risks and benefits
Locations (5)
- —Germany
- —Italy
- —Spain
- —France
- —Austria
Common questions
What is marginal zone lymphoma?
Marginal zone lymphoma is a type of cancer that affects a certain kind of white blood cell called lymphocytes. It's generally a slow-growing cancer.
What is a PET/CT scan?
A PET/CT scan is a special imaging test that combines two types of scans. It helps doctors see how well your body's cells are working and can pinpoint areas of disease, like cancer.
What's the difference between the two scans being compared?
Both are PET/CT scans, but they use slightly different substances (called 'tracers') to highlight areas in your body. The study wants to see if one tracer is better at finding marginal zone lymphoma cells than the other.
Will my treatment change if I join the study?
The study aims to see if these scans *impact* treatment planning, but your actual treatment decisions will always be made by your doctor based on all available information, including your study results.
Do I have to pay to be in the study?
No, you do not have to pay to participate in a clinical trial. All study-related procedures and scans will be covered.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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