Expanded Access [11C] Methionine PET Imaging

August 22, 2023 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Available
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXAMPT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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