Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2014
Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.
Клиническое исследование I фазыСтатьяПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Chin Bennett B, Kronauge James F, Femia Frank J, Chen Jianqing, Maresca Kevin P, Hillier Shawn, Petry Neil A, James Olga G, Oldan Jorge D, Armor Thomas, Stubbs James B, Stabin Michael G, Babich John W
Аннотация
UNLABELLED: A first-in-human phase 1 clinical study was performed on 12 healthy adults with a high-specific-activity carrier-free formulation of (123)I-iobenguane. Clinical data are presented on the behavior of this receptor-targeting imaging agent.
METHODS: Whole-body and thoracic planar and SPECT imaging were performed over 48 h for calculation of tissue radiation dosimetry and for evaluation of clinical safety and efficacy.
RESULTS: A reference clinical imaging database acquired over time for healthy men and women injected with high-specific-activity (123)I-iobenguane showed organ distribution and whole-body retention similar to those of conventional (123)I-iobenguane. The heart-to-mediastinum ratios for the high-specific-activity formulation were statistically higher than for conventional formulations, and the predicted radiation dosimetry estimations for some organs varied significantly from those based on animal distributions.
CONCLUSION: Human normal-organ kinetics, radiation dosimetry, clinical safety, and imaging efficacy provide compelling evidence for the use of high-specific-activity (123)I-iobenguane.
METHODS: Whole-body and thoracic planar and SPECT imaging were performed over 48 h for calculation of tissue radiation dosimetry and for evaluation of clinical safety and efficacy.
RESULTS: A reference clinical imaging database acquired over time for healthy men and women injected with high-specific-activity (123)I-iobenguane showed organ distribution and whole-body retention similar to those of conventional (123)I-iobenguane. The heart-to-mediastinum ratios for the high-specific-activity formulation were statistically higher than for conventional formulations, and the predicted radiation dosimetry estimations for some organs varied significantly from those based on animal distributions.
CONCLUSION: Human normal-organ kinetics, radiation dosimetry, clinical safety, and imaging efficacy provide compelling evidence for the use of high-specific-activity (123)I-iobenguane.
Предметные рубрики MeSH
3-IodobenzylguanidineAdultContrast MediaElectrocardiographyFemaleHealthy VolunteersHeartHumansIodine RadioisotopesMaleMediastinumMiddle AgedPhantoms, ImagingRadiation DosageRadiographic Image Interpretation, Computer-AssistedRadiometryRadiopharmaceuticalsTime FactorsTissue DistributionTomography, Emission-Computed, Single-PhotonWhole Body Imaging