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Active, Not Recruiting

NCT Number: NCT00840047

Methionine PET/CT Studies In Patients With Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Brain Tumors and/or Solid Tumors Including Brain Stem Glioma Craniopharyngioma Ependymoma Ewing Sarcoma Glioma Hemic and Lymphatic Diseases High Grade CNS Tumors Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Low Grade CNS Tumors Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Medulloblastoma Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Muscle Tissue Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Non Hodgkin Lymphoma Osteosarcoma Other Rhabdomyosarcoma Sarcoma Sarcoma, Ewing

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methionine

Drug

Intravenous injection

Other names: MET, [11C]-L-Methionine

Primary outcomes

  1. Success rate of methionine (MET) for visualizing tumors

    Time frame: Baseline

    To estimate the success rate of methionine (MET) for visualizing tumors at the time of diagnosis. We hypothesize that at least 70% of tumors within each group studied will be successfully visualized.

Secondary outcomes

  1. Association of methionine uptake with tumor grade

    Time frame: End of study (maximum of 3 years post methionine infusion and PET scan)

    Methionine uptake in tumors will be compared among tumor grades 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.

  2. Bio-distribution of MET in organs

    Time frame: At baseline, after enrollment of the first 93 participants

    Whole body scans will be acquired and descriptive statistics for MET uptake from other parts of the body will be provided.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2009
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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