Imaging Brain Tumors With FACBC and Methionine

NCT00597246 | Completed Results DMC

• 1 other identifier: 03-028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research protocol makes pictures of brain tumors. The pictures are made with a positron emission tomography (PET) scanner. PET scans use radioactivity to "see" cancer cells. We are using a new kind of PET scan. The new PET scan is called \[18F\]-FACBC PET. We will compare this to the standard PET scan. The standard PET scan is called \[11C\]-methionine PET. We expect these pictures will give us information about your tumor. We also hope to collect information about the amount of radioactivity exposure. We will measure radioactivity exposure to your tumor, brain and other organs. The research study results will be used to support the submission of an investigational new drug (IND) application to the Food and Drug Administration (FDA).

Conditions

Brain Cancer; CNS Cancer

Keywords

Brain; CNS; Central Nervous System

Outcome Measures

Primary Outcomes (1)

• Maximum Standardized Uptake Value of 3-[18F]-FACBC

  Determine clearance of 3-\[18F\]-FACBC in different tissues/organs of body.

  Duration of scan, an average of 1 hour

Secondary Outcomes (1)

• Rate of 18F-Fluciclovine Transport (k1) Into Tumors

  Duration of scan, an average of 1 hour

Study Arms (1)

1

EXPERIMENTAL

Drug: FACBC, Methionine; Other: PET Scan

Interventions

FACBC, Methionine DRUG

F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.

1

PET Scan OTHER

GE Advance PET scanner for sequential body imaging

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Registered patient at MSKCC.
• Child-bearing age females must be non-pregnant, non-lactating, and must be using adequate contraception or surgically sterile.
• Karnofsky score of 60 or greater.
• Children that can sit still for 60-90 minutes, without sedation, will be included in this protocol.

You may not qualify if:

• Patient cannot tolerate lying still for 90 minute sessions in the PET tomograph.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

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; Central Nervous System Neoplasms

Interventions

Methionine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids, Essential; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Neutral; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Ronald Blasberg, 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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: May 13, 2003
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2019-06

Locations

US (1)