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Expanded Access [11C] Methionine PET Imaging

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Available
CT.gov ID
NCT05511714
Collaborator
(none)
1
Location

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: L-(11C) methionine

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

Study Type:
Expanded Access
Official Title:
Expanded Access [11C] Methionine PET Imaging

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital

    Investigators

    • Principal Investigator: Barry L. Shulkin, MD, MBA, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05511714
    Other Study ID Numbers:
    • EXAMPT
    First Posted:
    Aug 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Aug 23, 2022