Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03541720
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT03541720
Study Brief:
Protocol Section:
NCT03541720