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Trial Title:
Expanded Access [11C] Methionine PET Imaging
NCT ID:
NCT05511714
Condition:
Central Nervous System Tumor
Head and Neck Neoplasms
Conditions: Official terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Head and Neck Neoplasms
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
L-(11C) methionine
Description:
Injected intravenously with 20 mCi/1.7 sq m body surface area of L-[methyl-11C]methionine
(maximum prescribed dose: 20 mCi).
Other name:
methionine C 11
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.
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Locations:
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Available
Contact:
Last name:
Barry L. Shulkin, MD, MBA
Phone:
866-278-5833
Email:
referralinfo@stjude.org
Investigator:
Last name:
Barry L. Shulkin, MD, MBA
Email:
Principal Investigator
Lead sponsor:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Source:
St. Jude Children's Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05511714
http://www.stjude.org
http://www.stjude.org/protocols
