This phase I/IIa trial studies meta-fluorine F18 fluorobenzylguanidine (18F-MFBG) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance (MR) in imaging patients with neuroendocrine malignancies. 18F-fluorine gives off radiation and is attached to MFBG, which allows the tumor to be detected by a PET/CT or PET/MR scanner. Researchers want to know how 18F-MFBG behaves in the body after injection, how it spreads and is removed from the body, and how long it stays in the blood. It may also help researchers determine whether 18F-MFBG PET/CT or PET/MR can be used to detect disease and perform scans faster and earlier compared to other routine imaging.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02348749.
PRIMARY OBJECTIVES:
I. To evaluate the pharmacokinetics, biodistribution and organ dosimetry of 18F-MFBG.
II. To evaluate the ability of 18F-MFBG to detect known sites of disease in patients with neuroblastoma.
SECONDARY OBJECTIVES:
I. To evaluate lesion targeting of 18F-MFBG as compared to 123-iodine metaiodobenzylguanidine (123I-MIBG) imaging in neuroendocrine (NE) tumors.
II. To evaluate the feasibility of Curie scoring for 18F-MFBG in comparison to 123I-MIBG imaging in neuroblastoma.
OUTLINE:
PHASE I: Patients receive meta-fluorine F18 fluorobenzylguanidine intravenously (IV) and undergo PET/CT scan over 20-60 minutes at 30 minutes post-injection, 1-2 hours post-injection, and 3-4 hours post-injection.
EXPANSION COHORT: Patients receive meta-fluorine F18 fluorobenzylguanidine IV and undergo PET/MR scan over 20-60 minutes (PET/CT scan if PET/MR is unavailable) at 60-90 minutes post-injection. Patients with positive lesion detected by meta-fluorine F18 fluorobenzylguanidine may be eligible for repeat imaging scan at the discretion of the principal investigator.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNeeta Pandit-Taskar