Overview
Eligibility
Design Details
Arms & Interventions
Outcome Measures
Trial Sites
Eligibility
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.
Design Details
AllocationN/A
Intervention ModelSingle Group Assignment
MaskingNone (Open Label)
Number to Enroll20
Arms & Interventions
Interventions
Type: Experimental
Description: 18F-DA will be injected into a vein in the arm or leg, or via central venous access line.
Outcome Measures
Primary Outcome Measures
Adverse event rateup to 2 days following injection of the radiotracer 18F-DA.
The adverse events will be recorded and monitored up to two days after the injection of radiotracer 18F-DA. The 95% CI for the adverse event rate will be calculated and reported. If one adverse event grade 2 or above, attributable to study drug, the study will be stopped until completion of IRB review and a decision about whether the study should be modified or closed.
Secondary Outcome Measures
The frequency of localization of 18F-DA in different organs.up to half year following injection of the radiotracer 18F-DA.
The localization of 18F-DA throughout the whole body will be described descriptively in different organs such as salivary glands, heart, liver, kidneys, bladder, and bowel. The frequency of the localization of 18F-DA in those regions will be listed. Unexpected sites of uptake, such as bone or focally within soft tissue, are not normal and will be considered abnormal and documented descriptively as well.
max SUV from 18F-DA and 123I-mIBG PETup to half year following injection of the radiotracer 18F-DA.
Standardized uptake values of soft tissue and tumor (SUV) will be generated by drawing regions of interest on the images scaled to SUV. Descriptive statistics of SUV values, such as max SUV, from 18F-DA and 123I-mIBG PET will be provided.
Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imagingup to half year following injection of the radiotracer 18F-DA.
The Curie scoring of 18F-DA and 123I-mIBG imaging will be scored for each participant. The difference of the Curie scoring between the two imaging will be calculated for each patient. Summary statistics of the difference such as mean and standard deviation would be calculated. One sample t test or signed rank test may be used to test whether the difference is equal to 0 depending on whether the distribution of the difference is normal or not.
Trial Sites
This study has 1 trial site
St. Jude Children's Research Hospital
Memphis, Tennessee, US