Methionine PET/CT Studies In Patients With Cancer | NCT00840047

Studies
Methionine PET/CT Studies In Patients With Cancer

NCT00840047

Sponsor

St. Jude Children's Research Hospital

Status

Active, not recruiting

Last Update Posted

Jun 17, 2026Actual

Enrollment

503Actual

Phase

Phase 2

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

Interventions

Methionine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2011-02414	Registry Identifier	NCI Clinical Trial Registration Program

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2009Actual

Primary Completion Date

Jul 27, 2027Estimated

Completion Date

Jul 27, 2027Estimated

First Submitted Date

Feb 9, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

503Actual

Label	Type	Description	Intervention Names
Participants	Experimental	Participants who meet the eligibility criteria in the study will receive methionine.	Drug: Methionine

Name	Type	Description	Arm Group Labels	Other Names
Methionine	Drug	Intravenous injection	Participants	MET

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Association of methionine uptake with tumor grade	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.	End of study (maximum of 3 years post methionine infusion and PET scan)

Other Outcomes

Not provided

Eligibility Module

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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Barry L Shulkin, MD	St. Jude Children's Research Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St. Jude Children's Research Hospital		Memphis	Tennessee	38119	United States

Label	URL
St. Jude Children's Research Hospital	View source
Clinical Trials Open at St. Jude	View source

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	May 10, 2021	Nov 26, 2024

ID	Term
D004806	Ependymoma
D008527	Medulloblastoma
D003397	Craniopharyngioma
D006689	Hodgkin Disease
D008228	Lymphoma, Non-Hodgkin
D012512	Sarcoma, Ewing
D012516	Osteosarcoma
D012208	Rhabdomyosarcoma
D009447	Neuroblastoma

Ancestor Terms

ID	Term
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue
D018242	Neuroectodermal Tumors, Primitive
D008223	Lymphoma
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D012509	Sarcoma
D009217	Myosarcoma
D009379	Neoplasms, Muscle Tissue
D018241	Neuroectodermal Tumors, Primitive, Peripheral

ID	Term
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals
D000601	Amino Acids, Essential
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D021542	Amino Acids, Neutral