The research is being done because metaiodobenzylguanidine (MIBG) is a chemical that has been used in many children to image their neuroblastoma. MIBG molecules can be put together with radioactive iodine (124I) in the laboratory to make radioactive 124I-MIBG (iodine I 124 metaiodobenzylguanidine). When children are given 124I-MIBG, it can be seen in their body after doing a positron emission tomography (PET)/computed tomography (CT) scan. PET/CT scans may allow researchers to image, or see, the tumors and different tissues/organs with a more precise outline than the standard 123I-MIBG scan. Researchers want to find out more information about using 124I-MIBG to see tumors and organs by using a PET/CT scan.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01583842.
PRIMARY OBJECTIVES:
I. To describe organ dosimetry using high specific activity (no carrier added) and low specific activity (carrier added) 124I-MIBG PET/CT in patients with refractory or relapsed neuroblastoma.
II. To describe acute toxicities associated with 124I-MIBG administration in patients with refractory or relapsed neuroblastoma.
SECONDARY OBJECTIVES:
I. To describe tumor dosimetry using high specific activity (no carrier added) and low specific activity (carrier added) 124I-MIBG PET/CT in patients with refractory or relapsed neuroblastoma.
II. To assess the accuracy of tumor imaging using 124I-MIBG PET/CT versus 123I-MIBG scan with 3-dimensional imaging by single-photon emission computed tomography (SPECT) or SPECT/CT by number, intensity of uptake and localization of sites of tumor.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive no-carrier 124I-MIBG intravenously (IV) over 1-2 minutes and undergo PET/CT scan on days 0, 1, 2, and 5. Patients also undergo iobenguane I 131 (131I-MIBG) PET/CT scan on days 7-9. Beginning 6 weeks after 131I-MIBG scan, patients may undergo additional 124I-MIBG scan.
COHORT II: Patients receive carrier 124I-MIBG IV over 60 minutes and undergo PET/CT scan on days 0, 1, 2, and 5. Patients also undergo 131I-MIBG PET/CT scan on days 7-9. Beginning 6 weeks after 131I-MIBG scan, patients may undergo additional 124I-MIBG scan.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorKatherine Kurshan Matthay