NCT03541720

18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neuroblastoma
• Pheochromocytoma

Interventions

Type	Name	Description
DRUG	18F-DA	18F-DA is an investigational PET radiotracer

Timeline

• Start date: 2019-04-30
• Primary completion: 2027-01-01
• Completion: 2028-07-01
• First posted: 2018-05-30
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study