Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03541720
Study type Interventional
Source St. Jude Children's Research Hospital
Contact Barry Shulkin, MD
Phone 866-278-5833
Email referralinfo@stjude.org
Status Recruiting
Phase Early Phase 1
Start date April 30, 2019
Completion date July 1, 2026

See also
  Status Clinical Trial Phase
Completed NCT00492167 - Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma Phase 1
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Active, not recruiting NCT03107988 - NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) Phase 1
Recruiting NCT04253015 - A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT03273712 - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) Phase 2
Recruiting NCT02933333 - G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Phase 4
Recruiting NCT00588068 - Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Recruiting NCT04301843 - Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma Phase 2
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Recruiting NCT04040088 - An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors Early Phase 1
Recruiting NCT06057948 - A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma Phase 2
Not yet recruiting NCT06335745 - PediCARE Health Equity Intervention in High-Risk Neuroblastoma N/A
Recruiting NCT02559778 - Pediatric Precision Laboratory Advanced Neuroblastoma Therapy Phase 2
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02245997 - Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma N/A
Not yet recruiting NCT01156350 - Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma Phase 2
Active, not recruiting NCT01192555 - Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma Phase 1/Phase 2
Completed NCT01222780 - To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer Phase 1