Overview

This trial is active, not recruiting.

Conditions brain cancer, gliomas
Treatment [18f]facbc pet and [18f]flt pet imaging
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Columbia University
Start date January 2009
End date January 2017
Trial size 30 participants
Trial identifier NCT00832598, 08-142

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
[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.

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.
time frame: 2 years

Secondary Outcomes

Measure
Compare [18F]FACBC PET & [18F]FLT PET results with MRI imaging in patients with recurrent gliomas (n=30).
time frame: 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)
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors
Principal investigator Ronald Blasberg, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.