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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00832598
First received: January 28, 2009
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Brain Cancer
Gliomas
 Radiation: [18F]FACBC PET and [18F]FLT PET imaging

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare [18F]FACBC PET & [18F]FLT PET results with MRI imaging in patients with recurrent gliomas (n=30). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Radiation: [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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832598

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Columbia University
Investigators
Principal Investigator: Ronald Blasberg, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00832598     History of Changes
Other Study ID Numbers: 08-142
Study First Received: January 28, 2009
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
18F-FACBC
PET scan imaging
08-142

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 21, 2013