FLOPET: PET Scan Studies to Analyze Neuroblastoma and Pheochromocytoma Tumors

Brief Summary

Neuroblastoma is the most common extracranial malignant tumor in children and has often spread to multiple sites before it is detected. The five-year neuroblastoma survival rate is only about 50% in children with widespread disease.

Nuclear imaging with the radiotracer ¹²³I-mIBG is the standard test to follow and manage these patients. Unfortunately, the imaging is somewhat blurry, which reduces our ability to find small areas of disease.

If left untreated, these areas can lead to tumor relapse.

To address this need for more sensitive and accurate tumor detection, this study will use positron emission tomography (PET), an advanced functional imaging technology that allows precise determination of radiotracer accumulation in tumors, to improve detection of small tumors and monitor therapy response. We will evaluate the effectiveness of PET scanning combined with the radiotracer ¹⁸F-fluorodopamine (¹⁸F-DA) in children with neuroblastoma and the closely related tumor, pheochromocytoma. ¹⁸F-DA has been shown to be safe and more effective than ¹²³I-mIBG in analyzing pheochromocytoma tumors.

Primary Objective

• Explore the safety of ¹⁸F-DA in patients with known or suspected neuroblastoma or pheochromocytoma

Eligibility Criteria

Inclusion criteria include:

• Known or suspected neuroblastoma or pheochromocytoma
• Positive findings on prior imaging within past 4 weeks
• At least 1 year old

Exclusion Criteria include:

• Pregnancy or lactation
• Use of medications known to interfere with ¹²³I-mIBG uptake
• Patient is younger than 3 years of age requiring a total length of anesthesia time greater than 3 hours

Study Sites

St. Jude Children’s Research Hospital, Memphis, Tennessee

About this study

Neuroblastoma is a solid tumor that most often develops on the adrenal glands, which are located above the kidneys. Pheochromocytoma is a tumor that is closely related to neuroblastoma. This study will evaluate a new way to help doctors diagnose these tumors.

In this study, we will use an imaging test called a PET (positron emission tomography) scan, combined with a drug, to find and analyze tumors. The drug is called a radioactive tracer. The PET scan and tracer work together to create a three-dimensional (3-D) picture of your child’s organs and tumor.

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 very small areas of the disease.

The purpose of this study is to find out if another radioactive tracer, called ¹⁸F-DA, is safe to use in children. This new tracer is made from two naturally occurring chemicals: dopamine and fluorine. Dopamine is present in our bodies, and fluorine occurs in nature. ¹⁸F-DA has been shown to be safe and more effective than ¹²³I-mIBG in analyzing pheochromocytoma.

Purpose of this clinical trial

The main goal of this study is to test the safety of ¹⁸F-DA in children with neuroblastoma or pheochromocytoma. Researchers also want to learn how ¹⁸F-DA moves throughout the body. Finally, they want to find out if ¹⁸F-DA could replace ¹²³I-mIBG in the future.

Eligibility overview

• Known or suspected neuroblastoma or pheochromocytoma
• At least 1 year old