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NCT05511714 Clinical Trial

Expanded Access [11C] Methionine PET Imaging

Head and Neck Neoplasms Clinical Trial

Official title:
Expanded Access [11C] Methionine PET Imaging

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05511714
Other study ID # EXAMPT
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date August 2023
Source St. Jude Children's Research Hospital
Contact Barry L. Shulkin, MD, MBA
Phone 866-278-5833
Email referralinfo@stjude.org
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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).

Locations
Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (1)
Lead Sponsor Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

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