[18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors
The purpose of this study is to help us understand gliomas, one type of brain tumor. This research protocol makes pictures of gliomas. We will take pictures of the glioma before and after treatment. The pictures are made with a positron emission tomography (PET) scanner. PET scans use radioactive markers to "see" cancer cells. We plan to use two different radioactive markers, [18F]FACBC and [18F]FLT, to "see" if the glioma responds to the treatment being recommended by the doctor. We are investigating whether one or both of these types of PET scans can help us to better understand gliomas and their response to treatment.
We expect these pictures will give us information the your tumor and may help us to understand why the treatment that the patient is receiving is affecting the tumor the way that it is. We also hope to collect information about the amount of radioactivity exposure. We will measure radioactivity exposure to the tumor, brain and other organs.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors|
- Determine & comp biodistribution, clearance, & dosimetry of [18F]FACBC & [18F]FLT tissue/organs w/i the field of view of the dynamic PET imag studies prior-to & during anti-AKT &/or anti-VEGF directed therapies alone or in combin with radia for glioma. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Compare [18F]FACBC PET & [18F]FLT PET results with MRI imaging in patients with recurrent gliomas (n=30). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Explore if [18F]FACBC PET and [18F]FLT PET imaging can be related to molecular markers (AKT, VEGFR, and related signaling/biologic changes by immunohistochemistry and/or analysis of flash frozen tissue) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: PET imaging
We will perform [18F]FACBC PET and [18F]FLT PET imaging on 30 patients with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
Radiation: [18F]FACBC PET and [18F]FLT PET imaging
[18F]FACBC PET and [18F]FLT PET imaging on 30 patients with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc. Patients with measurable disease on MRI will undergo PET imaging at baseline (prior-to) and after approximately 1 month of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832598
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ronald Blasberg, MD||Memorial Sloan Kettering Cancer Center.|