Brain Tumors and/or Solid Tumors IncludingPhase 2NCT00840047
Methionine PET/CT Studies In Patients With Cancer
A Phase 2 study testing Methionine in people with Brain Tumors and/or Solid Tumors Including and Brain Stem Glioma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumors and/or Solid Tumors Including, Brain Stem Glioma, High Grade CNS Tumors
- What is being tested?
- Methionine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2009to 27 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38119
About this study
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.
Read the 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
- Being tested
- Methionine
- Keywords
- Pediatric brain tumor, Pediatric solid tumor, Pediatric solid neoplasms
- Medical subject headings
- Ependymoma, Medulloblastoma, Craniopharyngioma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Sarcoma, Ewing, Osteosarcoma, Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethionineDrug
Also called MET, [11C]-L-Methionine
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants who meet the eligibility criteria in the study will receive methionine. Receives: Drug: Methionine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: End of study (maximum of 3 years post methionine infusion and PET scan)
Bio-distribution of MET in organs
Whole body scans will be acquired and descriptive statistics for MET uptake from other parts of the body will be provided.
Measured: At baseline, after enrollment of the first 93 participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study start20 Jul 2009
- Primary completion27 Jul 2027 (estimated)
- Study completion27 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumors and/or Solid Tumors IncludingStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry L Shulkin, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840047
- Sponsor's protocol ID
- METPET
- Other IDs
- NCI-2011-02414
- Status last verified
- Jun 2026
- First submitted
- 9 Feb 2009
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methionine PET/CT Studies In Patients With Cancer
- ClinicalTrials.gov ID
- NCT00840047
- Acronym / sponsor ID
- METPET
- Conditions
- Brain Tumors and/or Solid Tumors Including, Brain Stem Glioma, High Grade CNS Tumors, Ependymoma, Medulloblastoma, Craniopharyngioma
- Keywords
- Pediatric brain tumor, Pediatric solid tumor, Pediatric solid neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 503 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 20 Jul 2009 (actual)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 27 Jul 2027 (estimated)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Drug: MethionineParticipants who meet the eligibility criteria in the study will receive methionine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethionineAlso: MET, [11C]-L-MethionineIntravenous injection | Drug | Participants |
Primary outcome
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.
2 secondary outcomes
Association of methionine uptake with tumor grade
Time frame: End of study (maximum of 3 years post methionine infusion and PET scan)
Bio-distribution of MET in organs
Time frame: At baseline, after enrollment of the first 93 participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Diffuse Midline Glioma, H3 K27-Altered, Metastatic Malignant Neoplasm in the Central Nervous System
Active, not recruitingObservational study
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry L Shulkin, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methionine in people with Brain Tumors and/or Solid Tumors Including and Brain Stem Glioma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of methionine (MET) for visualizing tumors (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.