Methionine PET/CT Studies In Patients With Cancer

NCT00840047 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: METPETNCI-2011-02414
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric brain tumor; Pediatric solid tumor; Pediatric solid neoplasms

Outcome Measures

Primary Outcomes (1)

• Success rate of methionine (MET) for visualizing tumors

  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.

  Baseline

Secondary Outcomes (2)

• Association of methionine uptake with tumor grade

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

• Bio-distribution of MET in organs

  At baseline, after enrollment of the first 93 participants

Study Arms (1)

Participants

EXPERIMENTAL

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

Drug: Methionine

Interventions

Methionine DRUG

Intravenous injection

Also known as: MET, [11C]-L-Methionine

Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38119, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Ependymoma; Medulloblastoma; Craniopharyngioma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Sarcoma, Ewing; Osteosarcoma; Rhabdomyosarcoma; Neuroblastoma

Interventions

Methionine

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neuroectodermal Tumors, Primitive, Peripheral

Intervention Hierarchy (Ancestors)

Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids, Essential; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Neutral

Study Officials

• Barry L Shulkin, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 10, 2009
• Study Start: July 20, 2009
• Primary Completion (Estimated): July 27, 2027
• Study Completion (Estimated): July 27, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)