Expanded Access [11C] Methionine PET Imaging

NCT ID: NCT05511714

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Central Nervous System Tumor Head and Neck Neoplasms

Interventions

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L-(11C) methionine

Injected intravenously with 20 mCi/1.7 sq m body surface area of L-\[methyl-11C\]methionine (maximum prescribed dose: 20 mCi).

Intervention Type DRUG

Other Intervention Names

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methionine C 11

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* More than six L-\[11C\]methionine PET scans within the previous 12 months.
* Inability or willingness of patient, parent, or guardian to consent.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barry L. Shulkin, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status AVAILABLE

Countries

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United States

Central Contacts

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Barry L. Shulkin, MD, MBA

Role: CONTACT

866-278-5833

Facility Contacts

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Barry L. Shulkin, MD, MBA

Role: primary

866-278-5833

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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EXAMPT

Identifier Type: -

Identifier Source: org_study_id

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