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RecruitingPHASE3INTERVENTIONAL

Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets

This study is looking into a new way to treat lung cancer that has spread to the brain, called Non-Small Cell Lung Cancer (NSCLC) brain metastases. It uses a special ultrasound device called Exablate to temporarily open the natural protection around the brain, called the blood-brain barrier. The idea is that opening this barrier might help existing cancer drugs, called immune checkpoint inhibitors, reach the brain tumors more effectively. Researchers want to find out if this combination of Exablate with standard cancer medicines works better and is safe compared to receiving the standard medicines alone.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
InSightec
Enrolment target
30
Start
12 Aug 2022
Estimated completion
01 Dec 2027

What is this study about?

This study is about a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has sadly spread to the brain. When cancer spreads from one part of the body to another, it's called 'metastasis.' The brain has a natural protection system called the 'blood-brain barrier,' which is like a very strong filter. While this barrier protects the brain from harmful substances, it can also stop helpful cancer medicines from reaching tumors.

Researchers are using a special ultrasound device called 'Exablate' in this study. The Exablate device aims to temporarily and safely open this blood-brain barrier. The hope is that by doing this, the standard cancer medicines you might already be taking – a type of drug called immune checkpoint inhibitors – can get into the brain more easily and be more effective at fighting the brain tumors.

The study wants to compare two groups of patients. One group will receive their usual immune checkpoint inhibitor treatment along with the Exablate procedure. The other group will receive only their usual immune checkpoint inhibitor treatment. By comparing these two groups, the researchers hope to understand if adding the Exablate procedure is safer and more effective for treating NSCLC brain metastases.

Key takeaways

  • This study investigates a new way to treat lung cancer that has spread to the brain.
  • It uses a special ultrasound device called Exablate to help cancer drugs reach brain tumors.
  • The study compares Exablate plus standard care to standard care alone.
  • Participants will receive standard immune checkpoint inhibitor medicines.
  • Your general health and specific cancer details will determine if you can join.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, people need to be at least 18 years old and willing to follow all study instructions. You must have Non-Small Cell Lung Cancer that has spread to your brain, and your doctor must be planning for you to receive immune checkpoint inhibitor medicines as part of your treatment. The brain tumors need to be a certain size to be included in the study. You also need to be generally well enough to endure the study procedures, as assessed by your doctor.

There are also some reasons why you might not be able to join. For instance, if you have signs of bleeding in your brain, or if you have certain medical conditions that increase your risk of bleeding. If you are pregnant or planning to become pregnant during the study, you cannot take part. Additionally, if you are taking certain medications that can increase bleeding, or have active infections like Hepatitis B or C, you would not be able to join the study.

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 of age or older?
  2. Do you have Non-Small Cell Lung Cancer that has spread to your brain?
  3. Is your doctor planning for you to receive immune checkpoint inhibitor medicines?
  4. Are you generally well and able to manage daily activities?
  5. Are you not pregnant or planning to become so during the study?
  6. Do you have no history of significant bleeding problems or active severe infections?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups: either you'll receive the Exablate procedure along with your standard immune checkpoint inhibitor treatment, or you'll receive only your standard immune checkpoint inhibitor treatment. The immune checkpoint inhibitor treatment will usually be given every three weeks for up to six cycles, as prescribed by your doctor. The study will involve regular visits to track your health and how your brain tumors are responding. There will be follow-up appointments for at least six months. The total duration of your participation could vary depending on your treatment plan and how long you remain in the study.

Potential risks and benefits

Participating in this study might offer a potential benefit if the Exablate procedure helps your standard cancer medicines work better against your brain tumors. However, there are also potential risks involved with any medical procedure. The Exablate procedure itself has risks, and your doctor will discuss these with you in detail. There's always a chance that the treatment may not work, or that you might experience side effects. It's very important to remember that joining this study is completely your choice, and you have the right to withdraw at any time without affecting your future medical care.

Locations (10)

  • St. Joseph's Hospital and Medical Center
    Verified postcode
    Phoenix, United States· Not yet recruiting
  • Miami Cancer Institute at Baptist Health
    Verified postcode
    Miami, United States· Recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Recruiting
  • University of Maryland
    Verified postcode
    Baltimore, United States· Recruiting
  • Atrium Health Wake Forest Baptist
    Verified postcode
    Winston-Salem, United States· Recruiting
  • Oregon Health & Science University
    Verified postcode
    Portland, United States· Recruiting
  • Rhode Island Hospital
    Verified postcode
    Providence, United States· Recruiting
  • Johnston Willis Hospital
    Verified postcode
    Richmond, United States· Recruiting
  • Sunnybrook Research Institute
    Verified postcode
    Toronto, Canada· Completed
  • Samsung Medical Center
    Verified postcode
    Seoul, South Korea· Not yet recruiting

Common questions

What is the 'blood-brain barrier'?

It's a natural protective shield around your brain that prevents harmful substances from entering, but it can also block helpful medicines.

What is the Exablate device?

It's a special ultrasound device that is being tested to temporarily open the blood-brain barrier, allowing medicines to reach brain tumors more easily.

What are immune checkpoint inhibitors?

These are cancer medicines that help your body's own immune system fight cancer cells.

Will I know if I'm getting the Exablate treatment?

No, you will be randomly assigned to either receive the Exablate treatment or not, without you or your doctor choosing. This helps ensure the study results are fair.

How long will I be in the study?

Your participation will include receiving your cancer treatment and follow-up for at least six months, but the total time may vary.

How to find out more

Alyssa Voelker-Christy

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

Interested in taking part?

Register your interest

Share your details and the research team for "Blood-brain Barrier (BBB) Opening Using Exablate Focused Ult…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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