SNMMI Clinical Trials Network Research Series for Technologists: Introduction

Article Figures & Data

TABLE 1.

FDA-Approved Molecular Imaging and Therapeutic Radiopharmaceuticals from 2011 to 2021 (6,7)

Year of approval	Drug	Indication	Modality
2011	¹²³I-ioflupane (DaTscan; GE Healthcare)	Parkinson disease	Single-photon imaging
2012	¹⁸F-florbetapir (Amyvid; Eli Lilly)	Alzheimer disease	PET brain imaging
2012	¹¹C-choline (Mayo Clinic)	Prostate CANCER	PET oncology
2013	¹²³I-MIBG iobenguane (Progenics)	Pheochromocytoma, paraganglioma	Single-photon imaging
2013	²²³Ra-dichloride (Xofigo; Bayer Healthcare)	Prostate cancer	Radiopharmaceutical therapy
2013	¹⁸F-flutemetamol (Vizamyl; GE Healthcare)	Alzheimer disease	PET brain imaging
2014	¹⁸F-florbetaben (Neuraceq; Piramal)	Alzheimer disease	PET brain imaging
2016	¹⁸F-fluciclovine (Axumin; Blue Earth)	Prostate cancer	PET oncology
2016	⁶⁸Ga-DOTATATE (Netspot; AAA/Novartis)	Neuroendocrine cancer	PET oncology
2018	¹⁷⁷Lu-DOTATATE (Lutathera; AAA/Novartis)	Neuroendocrine cancer	Radiopharmaceutical therapy
2018	¹³¹I-MIBG iobenguane (Azedra; Progenics)	Pheochromocytoma, paraganglioma	Radiopharmaceutical therapy
2019	⁶⁸Ga-DOTATOC (University of Iowa)	Neuroendocrine cancer	PET oncology
2019	¹⁸F-fluorodopa (Feinstein Institute)	Parkinson disease	PET brain imaging
2020	¹⁸F-fluoroestradiol (Cerianna; Zionexa)	Breast cancer	PET oncology
2020	¹⁸F-flortaucipir (Tauvid; Lilly)	Alzheimer disease	PET brain imaging
2020	⁶⁴Cu-DOTATATE (Detectnet; RadioMedix-Curium)	Neuroendocrine cancer	PET oncology
2020	⁶⁸Ga PSMA-11 (UCSF–UCLA)	Prostate cancer	PET oncology
2021	¹⁸F-DCFPyL or ¹⁸F-piflufolastat (Pylarify; Lantheus)	Prostate cancer	PET oncology

TABLE 2.

Phases of Clinical Trials (16)

Phase	Primary purpose	Study participants
Preclinical	Collect data to determine basic physical, chemical, and biologic characteristics of new compound	Cell studies and animal studies
I	Safety in humans	Healthy volunteers or people with the disease or condition (usually 20–100 participants)
II	Efficacy in target/disease condition; determination of dose	People with the disease or condition (usually a few hundred participants)
III	Efficacy and monitoring of adverse events; comparison to current standard treatment	People with the disease or condition (often thousands of participants)
IV	Safety and efficacy over time, usually after FDA approval	People with the disease or condition (usually thousands of participants)