MOMENTUM-1: Phase II Study of 177Lu in Adults With Progressive Intracranial Meningioma - Clinical Trial
What is the Purpose of this Study?
This study has three parts: the beginning, the main part, and the follow-up.
At the beginning, doctors will check your body and brain, measure things like your blood pressure and temperature, take some blood for tests, and do scans and heart checks. You will also answer questions about how you feel.
Next, you will be placed into one of two groups by a computer. One group will get a special medicine called 177Lu Dotatate. The other group will get regular treatment. During this part, you will keep having checkups, blood tests, scans, and questions about how you feel. If you get the special medicine, you will have extra blood tests every two weeks to make sure it is safe.
At the end, doctors will do more checkups, take blood, and ask you questions about your health and feelings.
This study is for people who have a brain tumor called a meningioma. The tumor has come back or kept growing even after treatments like surgery, radiation, or medicine. The study wants to learn more about how to help these people.
Who Can Participate in the Study?
To be part of this study, a person must have a brain tumor called a meningioma that has been looked at under a microscope and given a grade from 1 to 3. The tumor must show up clearly on a special kind of brain scan. People cannot join the study if they have a certain condition called NF2-related schwannomatosis, if their tumor came from radiation, or if they have already had certain types of treatments that target a part of the tumor called SSTR2. They also cannot join if they have had a special kind of treatment called peptide receptor radionuclide therapy before signing up.
What is Involved?
This study is being done to find out if a special medicine called 177Lu-Dotatate works better or worse than the usual medicine for treating meningioma, which is a kind of brain tumor.
177Lu-Dotatate is a radioactive medicine. That means it gives off a type of energy called radiation. It goes straight to the tumor and sends radiation into it to try to shrink or stop it.
Study Details
