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

NCT00832598 | Completed Results

• 1 other identifier: 08-142
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Cancer; Gliomas

Keywords

18F-FACBC; PET scan imaging; 08-142

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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)

  2 years

Study Arms (1)

PET imaging

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.

Radiation: [18F]FACBC PET and [18F]FLT PET imaging

Interventions

[18F]FACBC PET and [18F]FLT PET imaging RADIATION

\[18F\]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.

PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Columbia University: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; 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

Results Point of Contact

• Title: Dr. Ronald Blasburg, MD
• Organization: Memorial Sloan Kettering Cancer Center

blasberr@mskcc.org

646-888-2211

Study Officials

• Ronald Blasberg, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 30, 2009
• Study Start: January 1, 2009
• Primary Completion: March 21, 2017
• Study Completion: March 21, 2017
• Last Updated: April 27, 2018
• Results First Posted: April 27, 2018

Record last verified: 2018-02

Locations

US (1)