This early phase I trial studies the side effects of fluorine F 18 (18F)-fluorodopamine positron emission tomography (PET) in diagnosing patients with neuroblastoma or pheochromocytoma. Diagnostic procedures, such as 18F-fluorodopamine PET, may help find and diagnose neuroblastoma or pheochromocytoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03541720.
PRIMARY OBJECTIVE:
I. To document the safety of fluorine F-18 6-fluorodopamine (18F-DA) as a positron emitting tracer in children with known or suspected neuroblastoma or pheochromocytoma.
SECONDARY OBJECTIVES:
I. Evaluate the biodistribution of 18F-DA in patients with neuroblastoma or pheochromocytoma.
II. Compare the biodistribution of 18F-DA with the biodistribution of iodine I 123 (123I)-iobenguane (mIBG).
EXPLORATORY OBJECTIVE:
I. Perform Curie scoring of 18F-DA PET images for comparison with Curie scoring of 123I-mIBG.
OUTLINE:
Patients receive fluorine F-18 6-fluorodopamine intravenously (IV). After 60 minutes, patients undergo PET over 15 minutes. Patients also undergo collection of blood and urine samples on study.
After completion of study, patients are followed up within 1-2 days.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorBarry Lynn Shulkin