18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

Who is this study for? Patients with Neuroblastoma (NB), Pheochromocytoma
What treatments are being studied? 18F-DA
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:

• Patients with known or suspected neuroblastoma or pheochromocytoma are eligible. 18F-DA PET/CT scanning will not be the initial imaging study in a newly diagnosed patient.

• Patients with positive findings on prior imaging within the past 4 weeks are eligible.

• Prior therapy is allowed.

• Patients \> 1 year of age, under the care of a SJCRH physician.

• Patients of both genders, and all ethnic groups, under the care of a SJCRH physician.

• Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.

• Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.

• Patients may undergo a repeat study one or more years following the initial FLOPET scan.

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Barry Shulkin, MD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date: 2019-04-30
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 20
Treatments
Experimental: Injection of 18F-DA
18F-DA will be injected into a vein in the arm or leg, or via central venous access line.
Sponsors
Leads: St. Jude Children's Research Hospital

This content was sourced from clinicaltrials.gov