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Imaging Brain Tumors With FACBC and Methionine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00597246
First received: January 9, 2008
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Brain Cancer
CNS Cancer
Drug: FACBC, Methionine
Other: PET Scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging Brain Tumors With FACBC and Methionine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Demonstrate [18F]-FACBC has equal or better brain tumor imaging characteristics compared to [11C]-methionine. Det biodistribution & clearance of 3-[18F]-FACBC in diff tissues/organs of body. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Look for potential correlations bet subsequent MR & PET results obtained from patients enrolled and patients' subsequent medical treatment, progression of tumor & survival. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2003
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: FACBC, Methionine
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.
Other: PET Scan
GE Advance PET scanner for sequential body imaging

Detailed Description:

The purpose of this research is to: 1) perform both 3-[18F]-FACBC and [11C-methyl]-Lmethionine brain tumor PET imaging studies in patients with primary brain tumors who have previously been treated and are now suspect for having recurrence or progression of disease (a pilot study, n=20); 2) perform only 3-[18F]-FACBC PET imaging studies on an additional set of patients with primary brain tumors who have previously been treated and are now suspect for having recurrence (n=10) . 3) obtain organ/tissue and body radiation dosimetry information following i.v. injection of 3-[18F]-FACBC; 4) look for potential correlations between the scan results obtained from those patients enrolled to 03-028 and the patients' past medical treatment; The first set of 20 patients will agree to two PET studies. One study will involve the i.v.

administration of a fluorine-18 labeled amino acid analogue, 3-fluoro-aminocyclobutane carboxylic acid (3-[18F]-FACBC) with sequential brain and body PET imaging. The second study will involve i.v. administration of [11C-methyl]-L-methionine and head imaging only.

The additional set of 10 patients will undergo one PET study which will consist of the i.v.

administration of fluorine-18 labeled amino acid analogue, 3-fluoro-aminocyclobutane carboxylic acid (3-[18F]-FACBC) with one brain scan and one body scan only. The 3-[18F]-FACBC PET studies (n=30) will be performed under the Radioactive Drug Research Committee (RDRC) guidelines as defined and established by the Federal Drug Administration (FDA). [11C-methyl]-L-methionine is in the hospital formulary and is approved for imaging brain tumors at MSKCC. Our hypotheses include: 1) [18F]-FACBC has equal or better brain tumor imaging characteristics compared to [11C]-methionine; 2) [18F]-FACBC is not metabolized, and radiolabeled metabolites will not confound the interpretation of the images as can be the case with [11C]-methionine; 3) imaging recurrent brain tumors with [18F]-FACBC will be enhanced by lower brain (background) activity as compared to corresponding [11C]- methionine images; 4) the biodistribution of [18F]-FACBC and radiation dosimetry following i.v. administration of a 370 MBq (10 mCi) dose is safe and within FDA guidelines; 5) a 370 MBq (10 mCi) dose of [18F]-FACBC is sufficient for imaging brain tumors in a clinical setting; 6) the accumulation of [18F]-FACBC will correlate with the patients response to prior treatment and will provide prognostic information with respect to tumor progression and survival.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient cannot tolerate lying still for 90 minute sessions in the PET tomograph.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597246

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
Investigators
Principal Investigator: Ronald blasberg, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00597246     History of Changes
Other Study ID Numbers: 03-028
Study First Received: January 9, 2008
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Brain
CNS
Central Nervous System

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014