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

Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832598
• Other study ID #: 08-142
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: March 26, 2018
• Start date: January 2009
• Est. completion date: March 21, 2017

Study information

• Verified date: February 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 21, 2017
• Est. primary completion date: March 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Central Nervous System Neoplasms
• Gliomas
• Nervous System Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years
Secondary	Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30).		2 years
Secondary	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)		2 years

External Links

•   Memorial Sloan-Kettering Cancer Center