Article Figures & Data
Tables
- 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 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)
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- Article
- Abstract
- OVERVIEW OF BASIC TERMS, CONCEPTS, AND PHASES OF CLINICAL TRIALS
- SERIES TOPIC 1: ETHICAL ISSUES IN CLINICAL RESEARCH
- SERIES TOPIC 2: APPLICATION OF GCP TO CLINICAL RESEARCH IN MEDICAL IMAGING
- SERIES TOPIC 3: CROS WITH APPLICATIONS IN CLINICAL IMAGING
- SERIES TOPIC 4: CLINICAL RESEARCH PRIMER—REGULATORY PROCESSES, PARTS I AND II (HOW AND WHEN RADIOPHARMACEUTICALS CAN BE USED AND THE ROLE OF THE IRB)
- SERIES TOPICS 5–7: USE OF IMAGING AGENTS IN THERAPEUTIC DRUG DEVELOPMENT AND APPROVAL, IMAGING AGENT TRIALS, AND IMAGING AGENTS WITH RADIOPHARMACEUTICAL THERAPIES IN CLINICAL TRIALS
- CONCLUSION
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