RecruitingNAINTERVENTIONAL

Preoperative Preradiotherapy TTFields

This study, called PORTRAIT, is looking into a new way to treat glioblastoma, a type of brain tumour. We're investigating if a device called Optune, which sends gentle electrical signals, can be safely used earlier than usual. Normally, Optune is used after surgery and chemotherapy. In this study, we're trying it *before* surgery and *before* radiotherapy. The main goal is to see if using Optune earlier can help stop the tumour from growing back quickly in the time between surgery and other treatments. This fast growth, known as 'rapid early progression', is a big problem. We hope this early use of Optune will improve how patients do in the long run. We're also checking how practical it is for patients to use the device during this new timeline.

At a glance

Status

Recruiting

Phase

Sponsor

The Christie NHS Foundation Trust

Enrolment target

Start

19 Dec 2024

Estimated completion

30 Dec 2026

Glioblastoma

What is this study about?

Glioblastoma is the most common type of cancerous brain tumour in adults. Despite treatments, it's a very challenging disease because the tumour often grows back. Standard treatment usually involves surgery to remove as much of the tumour as possible, followed by chemotherapy and radiotherapy. However, there's often a gap of about four to six weeks between surgery and these other treatments. During this time, some tumour cells don't receive any treatment, and unfortunately, a significant number of patients experience something called 'rapid early progression' (REP). This means the tumour starts to grow quickly again in that gap, which can sadly lead to a shorter survival time.

This study, called PORTRAIT, is trying to tackle the problem of rapid early progression. We're looking at a treatment called Tumour Treating Fields (TTFields), also known as Optune. This treatment involves wearing a cap with electrodes that send gentle electrical signals to the brain, which can disrupt cancer cell division. Optune has already been shown to help glioblastoma patients live longer when used after surgery and other treatments. Our researchers believe that starting Optune *before* surgery and continuing it *before* radiotherapy might prevent REP and improve overall outcomes for patients.

This is a 'Phase 1' study, which means its main purpose is to check if using Optune in this new, earlier way is safe and practical for patients. We'll be carefully monitoring participants and collecting information over a maximum of six months. We also have a group of patients who receive standard care at the same time, so we can compare the results and learn as much as possible about this new approach.

Key takeaways

Targets glioblastoma, a serious brain tumour.
Investigates earlier use of Optune treatment (before surgery and radiotherapy).
Aims to prevent 'rapid early progression' (tumour regrowth in treatment gaps).
Phase 1 study focusing on safety and practicality.
Involves wearing a device, extra scans, and samples.
Participation lasts a maximum of six months.

Who may be eligible?

To be considered for this study, you need to be over 35 years old and have been recently diagnosed with glioblastoma based on scans. Your medical team, which includes different specialists, must agree that taking part in the study is safe and suitable for you, and that it won't delay your surgery in a harmful way. You'll also need to be well enough for surgery and other treatments, and be able to understand and agree to take part.

If you join the part of the study where you use Optune, you must be able and willing to continuously shave your head to allow the device to work properly. You also need to be able and willing to wear the Optune equipment for the required amount of time each day. It’s important to discuss with your doctor whether you can commit to these aspects of the study.

However, you wouldn't be able to join if you have uncontrolled seizures, or if your doctors only plan for you to have a biopsy (a small tissue sample) rather than surgery. Additionally, if you have other types of cancer, except for certain types of skin cancer or prostate cancer that are very well controlled, you might not be eligible.

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.

Are you over 35 years old?
Have you been recently diagnosed with glioblastoma?
Are you generally well enough for surgery and other treatments?
Are you able and willing to shave your head regularly and wear a device?
Do you have mental capacity to understand and agree to join research?
Do you have uncontrolled seizures or other specific medical conditions that might exclude you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will use the Optune device before your surgery and then again between your surgery and your radiotherapy. You'll need to continuously shave your head for the device to work correctly and wear the equipment regularly. During the study, you'll have extra MRI scans beyond what's usually done, and you'll be asked to provide blood, tear fluid, and tissue samples. The study will last for a maximum of six months while we collect this information. After these six months, you will go back to your standard treatment plan as decided by your doctors. You'll still have follow-up appointments as part of your regular care.

Potential risks and benefits

Participating in this study might offer the potential benefit of starting glioblastoma treatment with Optune earlier than usual, which could help prevent rapid tumour growth between surgery and other treatments. However, this is a new approach, and we are primarily studying its safety and practicality. There are always potential risks with any medical treatment or study; for example, wearing the Optune device may cause skin irritation, and there will be additional scans and sample collections. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is the most common and aggressive type of cancerous brain tumour in adults.

What is Optune and how does it work?

Optune is a device that uses gentle electrical fields to disrupt the growth of cancer cells. You wear it on your head.

Why is this study trying Optune earlier?

Doctors want to see if using Optune before surgery and before radiotherapy can help stop the tumour from growing back quickly during that time, which is called 'rapid early progression'.

What does a 'Phase 1' study mean?

A Phase 1 study primarily checks if a new treatment approach is safe and practical for patients when used in a new way.

Will I have to shave my head?

Yes, if you join the Optune part of the study, you will need to continuously shave your head for the device to work properly.

How to find out more

Gerben R Borst, MD PhD

gerben.borst@nhs.net 0161 446 3000 Official trial record

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