Clinical trial NCT00832598: [18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors
Official title: 18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Cancer
Gliomas
Keywords: 18F-FACBC
PET scan imaging
08-142
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2009-01-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30).
timeFrame: 2 years
measure: 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)
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ronald Blasberg, MD
role: PRINCIPAL_INVESTIGATOR
References: