Pilot Study of MET-PET (L-[Methyl]-11C Methionine Positron Emission Tomography) to Evaluate for Treatment Response After Chemoradiation Therapy for Newly-diagnosed Glioblastoma
After agreeing to take part in this research study you will be asked to undergo some
screening tests or procedures to confirm that you are eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if it turns out
that you do not take part in the research study. If you have had some of these tests or
procedure recently, they may or may not have to be repeated. The screening process will
include the following: A medical history, performance status, physical exam, routine blood
tests, assessment of your tumor, diagnosis confirmation and pregnancy test. If these tests
show that you are eligible to participate in the research study, you will begin the study
treatment. If you do not meet the eligibility criteria, you will not be able to participate
in this research study.
Within 3 weeks after your surgery you will undergo a MET-PET scan to define residual
metabolic activity.
After completion of radiation therapy at 1,3,5,7,9 and 11 months following radiation therapy
you will undergo: a medical history, physical exam, assessment of your tumor by MRI,
documentation of your current dose of steroids, blood tests and an evaluation for side
effects.
At one month after the completion of radiation therapy you will undergo the second and final
MET-PET scan to assess response to therapy.
After the 11 month follow-up visit, we would like to keep track of your medical condition
for the rest of your life as part of our routine care. If we no longer see you in person in
the clinic, we would like to do this by calling you on the telephone once a year to see how
you are doing. Keeping in touch with you and checking your condition every year helps us
look at the long-term effects of the research study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Effect of C-11 methionine PET on progression free survival
PET uptake at 1 month after chemoRT (lesion/normal ratio) correlated with progression free survival
2 years
No
Kevin Oh, MD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
13-018
NCT01867593
May 2013
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |