[18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors

Study Overview
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Brief Summary
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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.

Official Title
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18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors

Conditions
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Gliomas, Brain Cancer

Intervention / Treatment
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* Radiation: [18F]FACBC PET and [18F]FLT PET imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered patient at MSKCC. Child-bearing age females must be non-pregnant,(documented by a negative pregnancy test within the last 2 weeks), non-lactating, and must be using adequate contraception or be surgically sterile. Patients with gliomas Patients planning to start anti-AKT and/or anti-VEGF directed therapies . Patients with measurable disease on MRI or CT neuroimaging. Exclusion Criteria: Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes). Patient cannot tolerate lying still for a 60 minute session in the PET tomograph.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET imaging<br>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<br>* [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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30). |  | 2 years | 
| 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) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-FACBC, PET scan imaging, 08-142