Purpose of this Study
If you decide to be part of the study, here's what will happen:
- You'll get check-ups and blood tests.
- Doctors will take pictures of your brain using special machines called CT or MRI.
- Your heart will be checked with a test called an ECG.
- You'll have a special treatment called Exablate to help medicine reach your brain better.
You might get up to 6 rounds of treatment over about 15 weeks, but only if the doctors thinks it's safe to keep going.
Who Can Participate?
Eligibility
Who Can Join the Study (Inclusion Criteria):
- Adults who are 18 years or older.
- People who have a type of lung cancer and are already getting a special kind of medicine called immune therapy.
- Their brain tumors must be very small (less than half a centimeter).
- They must be feeling well enough to do daily activities.
Who Cannot Join the Study (Exclusion Criteria):
- People who have bleeding in the brain or high pressure in the head.
- People who have problems that make them bleed easily.
- People who have had certain types of organ or stem cell transplants.
- People who have a disease that affects the brain and spinal cord.
- People who can't safely get an MRI scan (like if they have metal in their body or are very afraid of small spaces).
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
Scientists are doing a study to see if a special treatment called Exablate can help medicine get into brain tumors more easily. They are testing this on people who have lung cancer that has spread to their brain. The goal is to find out if this makes their medicine work better, especially when they are already getting a type of treatment called immune therapy.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
LIMITLESS: A randomized pivotal study assessing the efficacy of targeted blood-brain barrier (BBB) disruption using Exablate focused ultrasound during the standard of care treatment of brain metastases of non-small cell lung cancer (NSCLC) origin
Principal Investigator
Laura
Alder
Protocol Number
PRO00112599
NCT ID
NCT05317858
Phase
III
Enrollment Status
Pending Open to Enrollment