Methionine PET/CT Studies In Patients With Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer, Lymphoma, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/20/2018 |
| Start Date: | July 20, 2009 |
| End Date: | May 31, 2023 |
| Contact: | Barry L Shulkin, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 1-866-278-5833 |
The purpose of this study is to test the usefulness of imaging with radiolabeled methionine
in the evaluation of children and young adults with tumor(s). Methionine is a naturally
occurring essential amino acid. It is crucial for the formation of proteins. When labeled
with carbon-11 (C-11), a radioactive isotope of the naturally occurring carbon-12, the
distribution of methionine can be determined noninvasively using a PET (positron emission
tomography) camera. C-11 methionine (MET) has been shown valuable in the monitoring of a
large number of neoplasms. Since C-11 has a short half life (20 minutes), MET must be
produced in a facility very close to its intended use. Thus, it is not widely available and
is produced only at select institutions with access to a cyclotron and PET chemistry
facility. With the new availability of short lived tracers produced by its PET chemistry
unit, St. Jude Children's Research Hospital (St. Jude) is one of only a few facilities with
the capabilities and interests to evaluate the utility of PET scanning in the detection of
tumors, evaluation of response to therapy, and distinction of residual tumor from scar tissue
in patients who have completed therapy. The investigators propose to examine the
biodistribution of MET in patients with malignant solid neoplasms, with emphasis on central
nervous system (CNS) tumors and sarcomas. This project introduces a new diagnostic test for
the noninvasive evaluation of neoplasms in pediatric oncology. Although not the primary
purpose of this proposal, the investigators anticipate that MET studies will provide useful
clinical information for the management of patients with malignant neoplasms.
in the evaluation of children and young adults with tumor(s). Methionine is a naturally
occurring essential amino acid. It is crucial for the formation of proteins. When labeled
with carbon-11 (C-11), a radioactive isotope of the naturally occurring carbon-12, the
distribution of methionine can be determined noninvasively using a PET (positron emission
tomography) camera. C-11 methionine (MET) has been shown valuable in the monitoring of a
large number of neoplasms. Since C-11 has a short half life (20 minutes), MET must be
produced in a facility very close to its intended use. Thus, it is not widely available and
is produced only at select institutions with access to a cyclotron and PET chemistry
facility. With the new availability of short lived tracers produced by its PET chemistry
unit, St. Jude Children's Research Hospital (St. Jude) is one of only a few facilities with
the capabilities and interests to evaluate the utility of PET scanning in the detection of
tumors, evaluation of response to therapy, and distinction of residual tumor from scar tissue
in patients who have completed therapy. The investigators propose to examine the
biodistribution of MET in patients with malignant solid neoplasms, with emphasis on central
nervous system (CNS) tumors and sarcomas. This project introduces a new diagnostic test for
the noninvasive evaluation of neoplasms in pediatric oncology. Although not the primary
purpose of this proposal, the investigators anticipate that MET studies will provide useful
clinical information for the management of patients with malignant neoplasms.
The study focuses on the following objectives:
Primary objective:
- To estimate the success rate of Methionine (MET) for visualizing tumors at the time of
diagnosis. The study hypothesizes that at least 70% of newly diagnosed tumors within
each group will be studied and will be successfully visualized.
Secondary objective:
- To compare uptake of MET in tumors with tumor grade in patients with newly diagnosed or
relapsed, and/or persistent disease. Hypothesis: high grade tumors will concentrate
higher amounts of MET than lower grade tumors measured both qualitatively and
semi-quantitatively.
- To examine the bio-distribution of MET in organs that do not contain tumor, in
particular the lungs, heart, mediastinum, liver, spleen, pancreas, muscle, brain, and
bone marrow.
Exploratory objectives:
- To compare the findings on MET PET scans with those of standard imaging modalities,
principally MRI (magnetic resonance imaging) and FDG (fluorodeoxyglucose) PET CT
(computed tomography) at diagnosis, or at study enrollment for patients with relapsed
and or persistent disease, and for all patients over time.
- To compare the extent of abnormality on MRI with that of MET.
- To determine the presence or absence of elevated MET uptake beyond those of MRI defined
abnormality.
- To explore the relationship between MET uptake and prognosis.
Primary objective:
- To estimate the success rate of Methionine (MET) for visualizing tumors at the time of
diagnosis. The study hypothesizes that at least 70% of newly diagnosed tumors within
each group will be studied and will be successfully visualized.
Secondary objective:
- To compare uptake of MET in tumors with tumor grade in patients with newly diagnosed or
relapsed, and/or persistent disease. Hypothesis: high grade tumors will concentrate
higher amounts of MET than lower grade tumors measured both qualitatively and
semi-quantitatively.
- To examine the bio-distribution of MET in organs that do not contain tumor, in
particular the lungs, heart, mediastinum, liver, spleen, pancreas, muscle, brain, and
bone marrow.
Exploratory objectives:
- To compare the findings on MET PET scans with those of standard imaging modalities,
principally MRI (magnetic resonance imaging) and FDG (fluorodeoxyglucose) PET CT
(computed tomography) at diagnosis, or at study enrollment for patients with relapsed
and or persistent disease, and for all patients over time.
- To compare the extent of abnormality on MRI with that of MET.
- To determine the presence or absence of elevated MET uptake beyond those of MRI defined
abnormality.
- To explore the relationship between MET uptake and prognosis.
Inclusion Criteria:
- All participants under the care of St. Jude physicians with known or suspected
neoplastic disease are eligible for participation.
- Participants will have had, or are scheduled to have clinical imaging evaluations
which may include FDG PET CT, or CT, or MRI within 4 weeks of entry.
- No limit on age or gender.
- Female participants of childbearing age must not be lactating due to theoretical
potential harm to the infant from exposure to radiation.
- Informed consent signed by participant, parent, or guardian according to the
guidelines of the institutional review board.
Exclusion Criteria:
- More than 6 MET PET scans within the previous 12 months.
- Inability or unwillingness of research participant, parent, or legal
guardian/representative to give written informed consent.
Inclusion Criteria for Open-Access
- All participants under the care of St. Jude physicians with known or suspected
neoplastic disease are eligible for participation.
- No limit on age or gender
- Female participants of childbearing age must not be lactating due to theoretical
potential harm to the infant from exposure to radiation.
- Informed consent signed by participant, parent, or guardian according to the
guidelines of the institutional review board.
Exclusion Criteria for Open-Access
- More than 6 MET PET scans within the previous 12 months.
- Inability or unwillingness of research participant, parent, or legal
guardian/representative to give written informed consent.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Barry L Shulkin, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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