Expanded Access [11C] Methionine PET Imaging

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Expanded Access
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05511714
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	St. Jude Children's Research Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Barry L. Shulkin, MD, MBA
Principal Investigator Affiliation	St. Jude Children's Research Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Available
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Central Nervous System Tumor, Head and Neck Neoplasms
Study Website:	View Trial Website

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Available

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Barry L. Shulkin, MD, MBA

[email protected]

866-278-5833