NCT03541720Active, not recruitingEarly phase 1
18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 2 May 2018
- Start date
- 30 Apr 2019
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT03541720
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 13
- From 30 Apr 2019 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications known to interfere with 123I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48 hours, and labetalol which needs to be discontinued for 6 weeks).
Age
- Patients less than 3 years of age who require a total length of anesthesia time greater than 3 hours (for the FLOPET scan in conjunction with another clinical procedure requiring sedation) will be excluded from the study.
Other
- Inability or unwillingness of patient, parent, or guardian to consent.
- Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation. Patients should not become pregnant within one month of completion of 18F-DA PET scan.
Who the study is looking for
- 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.
Age in the registry: 1 year to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.