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Imaging Brain Tumors With FACBC and Methionine


N/A
N/A
N/A
Open (Enrolling)
Both
Brain Cancer, CNS Cancer

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Trial Information

Imaging Brain Tumors With FACBC and Methionine


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

6 years

Safety Issue:

No

Principal Investigator

Ronald blasberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-028

NCT ID:

NCT00597246

Start Date:

May 2003

Completion Date:

May 2013

Related Keywords:

  • Brain Cancer
  • CNS Cancer
  • Brain
  • CNS
  • Central Nervous System
  • Brain Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021