Methionine PET/CT Studies In Patients With Cancer

NCT ID: NCT00840047

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-20
• Study Completion Date: 2027-07-27

Brief Summary

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.

Detailed Description

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.

Conditions

Brain Tumors and/or Solid Tumors Including; Brain Stem Glioma; High Grade CNS Tumors; Ependymoma; Medulloblastoma; Craniopharyngioma; Low Grade CNS Tumors; Hodgkin Lymphoma; Non Hodgkin Lymphoma; Ewing Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Neuroblastoma; Other

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Participants

Participants who meet the eligibility criteria in the study will receive methionine.

Group Type: EXPERIMENTAL

Methionine

Intervention Type: DRUG

Intravenous injection

Interventions

Methionine

Intravenous injection

Intervention Type: DRUG

Other Intervention Names

MET; [11C]-L-Methionine

Eligibility Criteria

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.

• 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

• 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.

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry L Shulkin, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

METPET

Identifier Type: -

Identifier Source: org_study_id

NCI-2011-02414

Identifier Type: REGISTRY

Identifier Source: secondary_id