Pilot Study Comparing 68Ga-DOTATATE PETCT and 123I-MIBG Scans for Neuroblastoma in Children and Young Adults

What this Trial Is About

Neuroblastoma is the most common extracranial tumor in children, occurring at a rate of about 10.2 cases per million yearly. This study is a phase II pilot trial designed to assess the use of a new imaging method, 68Ga-DOTATATE PETCT, for detecting neuroblastoma and compare it to the existing 123I-MIBG scan. Researchers aim to evaluate the feasibility and safety of 68Ga-DOTATATE and how accurately it identifies neuroblastoma lesions compared to 123I-MIBG. Participants will first undergo a 123I-MIBG scan followed by a 68Ga-DOTATATE PETCT scan a few days later. The 68Ga-DOTATATE is a radiopharmaceutical injected into the patient, and imaging is done approximately one hour post-injection, lasting about two hours. This single-arm study includes children and young adults up to 21 years old who have biopsy-proven or suspected neuroblastoma. The study monitors adverse events within 24 hours after the 68Ga-DOTATATE injection. During the study, researchers will collect clinical data from the imaging scans and participants medical records for up to two years, including demographics, treatments, medications, pathology, and laboratory tests. Outcome measurements focus on the rate of participant enrollment and any side effects from the 68Ga-DOTATATE injection, as well as lesion detection and differences between the two imaging methods. Participants health status will be followed regularly to assess the imaging techniques effectiveness and safety.

68Ga-DOTATATE Neuroblastoma Imaging Pilot