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

Not Applicable

Completed

• Conditions: Brain Cancer; Gliomas
• Interventions: Radiation: [18F]FACBC PET and [18F]FLT PET imaging

• Registration Number: NCT00832598
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Primary Completion: 2017-03-21
• Study Completion: 2017-03-21
• Status Verified: 2018-02
• Results First Submitted: 2018-02-22
• Results First Submitted QC: 2018-03-26
• Last Update Submitted: 2018-03-26
• Results First Posted: 2018-04-27
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET imaging	[18F]FACBC PET and [18F]FLT 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States