AuthorisedTherapeutic exploratory (Phase II)Interventional

68Ga/177Lu-PSMA theranostics in recurrent grade 3 and grade 4 glioma

This research trial is investigating a new treatment for adults in the UK who have a type of aggressive brain tumour called grade 3 or grade 4 glioma, which has returned. The treatment, called 177Lu-PSMA, is being studied to understand if it is safe and if it can help control the tumour's growth. Researchers will carefully check for any side effects and see how long people live after starting this treatment, looking at periods of 6 months and 1 year. They will also measure the radiation levels going to the tumour and other important body parts. This is a Phase II study, meaning it's an earlier stage trial designed to explore the treatment's usefulness and safety in a smaller group of people.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Norwegian University Of Science And Technolology

Enrolment target

Start

14 Oct 2024

Recurrent grade 3 and grade 4 glioma

What is this study about?

This study is looking at a new way to treat a type of brain tumour called glioma, specifically grade 3 and grade 4, which are considered more aggressive forms. Sometimes, these tumours can come back even after initial treatment. This trial is investigating a treatment called 177Lu-PSMA Theranostics. 'Theranostics' is a combination of 'therapeutics' (treatment) and 'diagnostics' (finding out details about the illness). It means this approach can both find and treat the cancer.

The main goals of this study are to see if this new treatment is safe and if it helps control the tumour. Researchers will be carefully monitoring participants for any side effects that might occur. They also want to understand how effective the treatment is by looking at how long people live without their tumour growing (called progression-free survival) and their overall survival rate over 6 months and 1 year.

Beyond safety and initial effectiveness, the study will also measure how much radiation reaches the tumour itself and other important organs. They will check the tumour's response using special scans and also monitor how the treatment affects a person's general well-being and quality of life. This information will help doctors understand more about this potential treatment and whether it could be a good option for future patients.

Key takeaways

This trial is for adults with recurrent grade 3 or 4 glioma.
It tests a new treatment called 177Lu-PSMA Theranostics.
The main goals are to check treatment safety and effectiveness.
Participation involves injections, scans, and health assessments.
You can stop participating at any time.
It's a research study, not a guaranteed cure.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Most importantly, you must have been diagnosed with a specific type of aggressive brain tumour called grade 3 or grade 4 glioma, and this tumour must have returned after previous treatments.

There will be other medical checks and tests to make sure that the treatment is suitable and safe for you, and that participating in the study would not put your health at unnecessary risk. Your specialist doctor will talk through all the criteria with 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.

Am I 18 years old or older?
Do I have a diagnosis of grade 3 or grade 4 glioma?
Has my glioma returned after previous treatment?
Am I generally well enough to participate in a clinical study?
Am I able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the 177Lu-PSMA treatment as an injection. Throughout the study, you'll have regular hospital visits for assessments. These will include check-ups for any side effects using a standard medical guide, and you'll be asked to fill out questionnaires about your well-being. Doctors will use special MRI scans to check how your tumour is responding and conduct neurological exams to assess brain function. You’ll also have blood tests to monitor different aspects of your health. The study involves regular follow-up appointments after your treatment cycles to see how you are doing over time. The total duration of your participation will include the treatment period and follow-up examinations, with key outcomes assessed at 6 months and 1 year.

Potential risks and benefits

Participating in a study like this might offer a potential benefit of receiving a new treatment that isn't widely available yet, which could help control your tumour. However, like all medical treatments, there are potential risks, and you might experience side effects. These will be carefully monitored, and doctors will explain all known possibilities before you decide to join. It is very important to understand that you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Norway

Common questions

What is 'glioma'?

Glioma is a common type of brain tumour that starts in the glial cells, which support nerve cells. Grade 3 and 4 are more aggressive types.

What does 'recurrent' mean?

Recurrent means that the tumour has come back after it was treated before. This study is for people whose glioma has returned.

What is 177Lu-PSMA?

It's a new treatment that uses a mild radioactive substance (177Lu) attached to a molecule (PSMA) that targets cancer cells, helping to treat them while limiting harm to healthy cells.

Is this a new treatment?

Yes, this is an investigational treatment being tested in a clinical trial. It's not yet a standard treatment for glioma.

Will I get better if I join this trial?

We cannot guarantee that you will get better. Clinical trials are designed to find out if new treatments are safe and effective. Your doctors will discuss what this means for you.