18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · May 17, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique using a special substance called 18F-fluorodopamine (18F-DA) to help doctors better see and analyze tumors in children with neuroblastoma and pheochromocytoma. Currently, the most common method uses a different substance called 123I-mIBG, which sometimes doesn't provide clear images of very small tumors. The goal of this study is to find out if 18F-DA is safe for kids, see how it works in the body, and compare it to 123I-mIBG to see if it could be a better option in the future.

To participate in this trial, children over 1 year old with known or suspected neuroblastoma or pheochromocytoma can enroll, as long as they are under the care of a doctor at St. Jude and have had recent imaging done. Approximately 20 participants will take part in this pilot study. Parents and guardians will need to give their consent for their child to join. Participants can expect to undergo a PET scan with 18F-DA, and the study team will monitor them closely throughout the process to ensure their safety.

Gender

ALL

Eligibility 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.