Using a new imaging technique to analyze tumors in children with neuroblastoma and pheochromocytoma
18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
This study is testing a new type of PET scan using a special tracer to see if it can better identify and analyze tumors in children with neuroblastoma or pheochromocytoma compared to the standard imaging method.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT03541720 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of 18F-fluorodopamine (18F-DA) PET scans for identifying and analyzing tumors in pediatric patients with known or suspected neuroblastoma or pheochromocytoma. The research aims to compare the biodistribution of 18F-DA with the standard imaging agent 123I-mIBG, which often provides unclear images. Participants will receive a small dose of 18F-DA via intravenous injection, followed by a PET scan to evaluate the localization of the tracer in the body. The study will involve approximately 20 patients at St. Jude Children's Research Hospital.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients over 1 year of age with known or suspected neuroblastoma or pheochromocytoma.
Not a fit: Patients who are pregnant or lactating will not benefit from this study due to potential risks associated with radiation exposure.
Why it matters
Potential benefit: If successful, this study could lead to improved imaging techniques that allow for better detection of small tumor areas, potentially reducing the risk of tumor relapse.
How similar studies have performed: While the use of 18F-DA for PET imaging is a novel approach, previous studies have indicated its safety and effectiveness in analyzing pheochromocytoma, suggesting potential for success in neuroblastoma imaging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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). 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.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Barry Shulkin, MD — St. Jude Children's Research Hospital
- Study coordinator: Barry Shulkin, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.