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

NCT ID: NCT00832598

Last Updated: 2018-04-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2017-03-21

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.

Detailed Description

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Conditions

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Brain Cancer Gliomas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

[18F]FACBC PET and [18F]FLT PET imaging

Intervention Type RADIATION

\[18F\]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.

Interventions

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[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.

Intervention Type RADIATION

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Blasberg, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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08-142

Identifier Type: -

Identifier Source: org_study_id

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