Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Neuroblastoma
  • Pheochromocytoma
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 18F-DA scans will be performed within 4 weeks of standard imaging evaluations, such as CT (computed tomography) and I-123mIBG scanning. 18F-DA will be injected into a vein in the arm or leg, or via central venous access line.Masking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 1 years and 125 years
Gender
Both males and females

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 some...

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.

Tracking Information

NCT #
NCT03541720
Collaborators
Not Provided
Investigators
Principal Investigator: Barry Shulkin, MD St. Jude Children's Research Hospital