18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

Neuroblastoma is the most common extracranial malignant tumor of childhood. Nuclear imaging
with 123I-mIBG is the standard test to follow and manage these patients. Because of the
inherent imaging characteristics of I-123, there is suboptimal resolution within the images,
causing them to appear somewhat blurry, which reduces our ability to find small areas of
disease. A chemical that uses positron emission tomography should allow much better
resolution of the images, which could improve patient care by allowing us to find small areas
of disease that, if untreated, could result in tumor relapse. We have developed
18F-fluorodopamine (18F-DA) for PET imaging in our patients with neuroblastoma.

The primary objective is to explore the safety of 18F-DA in patients with known or suspected
neuroblastoma or pheochromocytoma. The secondary objectives are to evaluate the
biodistribution of 18F-DA in patients with neuroblastoma and compare the biodistribution of
18F-DA with the biodistribution of 123I-mIBG.

Patients receive an intravenous injection of a small (tracer) dose of 18F-DA. Approximately 1
hour later, patients undergo PET scanning of the entire body to evaluate the localization of
the tracer.

Inclusion Criteria:

Patients with known or suspected neuroblastoma or pheochromocytoma are eligible. 18F-DA
PET/CT scanning will not be the initial imaging study in a newly diagnosed patient.

Patients with positive findings on prior imaging within the past 4 weeks are eligible.

Prior therapy is allowed.

Patients > 1 year of age, under the care of a SJCRH physician.

Patients of both genders, and all ethnic groups, under the care of a SJCRH physician.

Female participants of childbearing 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:

Inability or unwillingness of patient, parent, or guardian to consent.

Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation.
Patient should not become pregnant within one month of completion of 18F-DA PET scan.

Use of medications known to interfere with 123I-mIBG uptake (principal considerations are
phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48
hours, and labetalol which needs to be discontinued for 6 weeks).

Patients less than 3 years of age who require a total length of anesthesia time greater
than 3 hours (for the FLOPET scan in conjunction with another clinical procedure requiring
sedation) will be excluded from the study.