18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

Running, not enrolling · Early Phase 1

Conditions studied: Neuroblastoma, Pheochromocytoma

In brief

PET (positron emission tomography) scans combined with a radioactive tracer will be used to identify and analyze tumors. Currently, the most common tracer used to analyze neuroblastoma tumors is called 123I-mIBG. However, the picture it provides is not always clear enough to see the very small areas of the disease. 18F-DA (18F-fluorodopamine) has been shown to be safe and more effective than 123I-mIBG in analyzing the tumor pheochromocytoma, which is closely related to neuroblastoma. With this research study, the investigators plan to meet the following goals: * Investigate to see if 18F-DA is safe to administer to pediatric patients with known or suspected neuroblastoma or pheochromocytoma * Examine where in the body 18F-DA goes. * Obtain information comparing 18F-DA to 123I-mIBG to see if 18F-DA could replace 123I-mIBG in the future. About 20 people, with known or suspected neuroblastoma or pheochromocytoma, will take part in this Pilot study at St. Jude.

Key facts

Study ID

NCT03541720

Run by

St. Jude Children's Research Hospital

People needed

13

Starts

2019-04-30

Expected to finish

2028-07-01

Last updated by the study team

2026-06-17

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients may undergo a repeat study one or more years following the initial FLOPET scan.

You may not qualify if…

• Inability or unwillingness of patient, parent, or guardian to consent.
• Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation. Patients 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.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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