Imaging Brain Tumors With FACBC and Methionine
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/6/2018 |
| Start Date: | May 13, 2003 |
| End Date: | May 2019 |
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).
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).
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.
[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.
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