89Zr-DFO-SC16.56 PET/CT for the Diagnosis of Neuroendocrine Tumors

Inclusion Criteria

• Signed, informed consent
• Age 4 or more years
• Histologically confirmed, SCLC (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor (Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI’s discretion) OR * Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial, OR * Histologically confirmed or suspected primary brain neoplasm OR * Desmoplastic small round cell tumors, osteosarcoma, Ewing’s sarcoma, rhabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients
• * At least one tumor lesion on CT** or magnetic resonance imaging (MRI) ≥ 0.8 cm OR * Tumor detectable fluorodeoxyglucose (FDG) PET, prostate specific membrane antigen (PSMA) PET, DOTATATE PET, metaiodobenzylguanidine (MIBG) single photon emission computed tomography (SPECT) (or planar MIBG scan if SPECT unavailable) OR * MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks ** Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET/CT scan) may be used at PI’s discretion
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Performance Status: Subjects must have a Lansky (< 16 years of at least 40)
• Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
• Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC * For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy
• While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment. The guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET/CT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems it is not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET/CT-guided biopsy

Exclusion Criteria

• History of anaphylactic reaction to humanized or human antibodies
• Pregnant or breast feeding
• Psychiatric illness that would interfere with compliance with the study procedures
• Inability to undergo PET scan due to weight limit
• Patients who require anesthesia or monitored sedation to tolerate PET scan procedure