Central Nervous System TumorNCT05511714
Expanded Access [11C] Methionine PET Imaging
A study testing L-(11C) methionine in people with Central Nervous System Tumor and Head and Neck Neoplasms, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System Tumor, Head and Neck Neoplasms
- What is being tested?
- L-(11C) methionine
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Child, Adult, Older adult
Who may be able to join
- All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation.
- No limit on age.
- Patients of all genders and all ethnic groups under the care of a SJCRH physician.
- Female participants of child-bearing 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 six L-[11C]methionine PET scans within the previous 12 months.
- Inability or willingness of patient, parent, or guardian to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Barry L. Shulkin, MD, MBA, 888-226-4343, referralinfo@stjude.org
Barry L. Shulkin, MD, MBA
About this study
The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment.
Primary Objective
To provide expanded access to L-[11C]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.
Read the detailed description
Participants receive an intravenous injection of a small (tracer) dose of L-[11C]methionine. Approximately 10 minutes later, patients undergo PET scanning to evaluate localization of the tracer.
- Being tested
- L-(11C) methionine
- Medical subject headings
- Central Nervous System Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-(11C) methionineDrug
Also called methionine C 11
Injected intravenously with 20 mCi/1.7 sq m body surface area of L-[methyl-11C]methionine (maximum prescribed dose: 20 mCi).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TumorStudies 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
- Expanded access
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, MBA, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511714
- Sponsor's protocol ID
- EXAMPT
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access [11C] Methionine PET Imaging
- ClinicalTrials.gov ID
- NCT05511714
- Acronym / sponsor ID
- EXAMPT
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- First posted
- 23 Aug 2022 (actual)
- 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 participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment.
Primary Objective
To provide expanded access to L-[11C]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.
Detailed description
Participants receive an intravenous injection of a small (tracer) dose of L-[11C]methionine. Approximately 10 minutes later, patients undergo PET scanning to evaluate localization of the tracer.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation.
- No limit on age.
- Patients of all genders and all ethnic groups under the care of a SJCRH physician.
- Female participants of child-bearing 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 (2 listed)
- More than six L-[11C]methionine PET scans within the previous 12 months.
- Inability or willingness of patient, parent, or guardian to 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 |
|---|---|---|
| L-(11C) methionineAlso: methionine C 11Injected intravenously with 20 mCi/1.7 sq m body surface area of L-[methyl-11C]methionine (maximum prescribed dose: 20 mCi). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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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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, MBA 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 study testing L-(11C) methionine in people with Central Nervous System Tumor and Head and Neck Neoplasms, 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barry L. Shulkin, MD, MBA (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Apr 2026.