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

Primary Purpose

Brain Cancer, Gliomas

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
[18F]FACBC PET and [18F]FLT PET imaging
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Cancer focused on measuring 18F-FACBC, PET scan imaging, 08-142

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET imaging

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30).
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)

Full Information

First Posted
January 28, 2009
Last Updated
March 26, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT00832598
Brief Title
[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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Columbia University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Gliomas
Keywords
18F-FACBC, PET scan imaging, 08-142

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET imaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
[18F]FACBC PET and [18F]FLT PET imaging
Intervention Description
[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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30).
Time Frame
2 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Blasberg, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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