FLOPET: PET Scan Studies to Analyze Neuroblastoma and Pheochromocytoma Tumors

18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

Category:

Solid Tumor

Diseases Treated:

Neuroblastoma, pheochromocytoma

Eligibility Overview:

This study is open to St. Jude patients only.

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

 

  1. 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

  2. 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
  3. FLOPET Quick View
    Sponsor St. Jude Children's Research Hospital
    Clinicaltrials.gov identifier NCT03541720
    Trial start date September 2018
    Estimated enrollment 20
    Study type Interventional
    Study phase Early Phase I
    Conditions

    Neuroblastoma, pheochromocytoma

    Ages 1 year and older
    Principal investigator Barry Shulkin, MD
    Study site St. Jude Children’s Research Hospital
    For a consultation or to discuss FLOPET St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.