Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2013
Measured human dosimetry of 68Ga-DOTATATE.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАПоддержка правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Walker Ronald C, Smith Gary T, Liu Eric, Moore Brandon, Clanton Jeff, Stabin Michael
Аннотация
UNLABELLED: Measured human dosimetry of the (68)Ga-labeled synthetic somatostatin analog (68)Ga-DOTATATE has not been reported in the peer-reviewed literature. (68)Ga-DOTATATE is an investigational PET/CT imaging agent that binds with high affinity to somatostatin receptor subtype 2, found on many human cancers, most classically neuroendocrine tumors but also others. Reporting of measured dosimetry of (68)Ga-DOTATATE could be useful for investigations for diagnosis, staging, and restaging of somatostatin receptor-expressing tumors.
METHODS: We performed measured dosimetry with (68)Ga-DOTATATE PET/CT scanning in 6 volunteer human subjects as part of an Institutional Review Board-approved biodistribution investigation of the use of this radiopharmaceutical for possible future use in the diagnosis of indeterminate lung nodules or lung cancer. Five subjects were imaged at 3 time points, and 1 subject was imaged at 2 time points. Dosimetry was then measured for the whole body and for specific organs.
RESULTS: There were no observed adverse events to the radiopharmaceutical in the immediate or delayed time frames, with a follow-up of 1 y. One patient had stage IV non-small cell lung cancer and remains alive but with disease progressing on treatment. For the other 5 patients, it was ultimately proven that they had benign nodules. The measured dosimetry shows that the critical organ with (68)Ga-DOTATATE is the spleen, followed by the uroepithelium of the bladder, the kidneys, and the liver, in that order. Organ-specific and whole-body dosimetries for (68)Ga-DOTATATE were similar to but often slightly greater than those for (68)Ga-DOTATOC or (68)Ga-DOTANOC but less than those for (111)In-diethylenetriaminepentaacetic acid-octreotide.
CONCLUSION: No toxicity was observed in our 6 patients, and no adverse events occurred. The measured human dosimetry of (68)Ga-DOTATATE is similar to that of other (68)Ga-labeled somatostatin receptor analogs.
METHODS: We performed measured dosimetry with (68)Ga-DOTATATE PET/CT scanning in 6 volunteer human subjects as part of an Institutional Review Board-approved biodistribution investigation of the use of this radiopharmaceutical for possible future use in the diagnosis of indeterminate lung nodules or lung cancer. Five subjects were imaged at 3 time points, and 1 subject was imaged at 2 time points. Dosimetry was then measured for the whole body and for specific organs.
RESULTS: There were no observed adverse events to the radiopharmaceutical in the immediate or delayed time frames, with a follow-up of 1 y. One patient had stage IV non-small cell lung cancer and remains alive but with disease progressing on treatment. For the other 5 patients, it was ultimately proven that they had benign nodules. The measured dosimetry shows that the critical organ with (68)Ga-DOTATATE is the spleen, followed by the uroepithelium of the bladder, the kidneys, and the liver, in that order. Organ-specific and whole-body dosimetries for (68)Ga-DOTATATE were similar to but often slightly greater than those for (68)Ga-DOTATOC or (68)Ga-DOTANOC but less than those for (111)In-diethylenetriaminepentaacetic acid-octreotide.
CONCLUSION: No toxicity was observed in our 6 patients, and no adverse events occurred. The measured human dosimetry of (68)Ga-DOTATATE is similar to that of other (68)Ga-labeled somatostatin receptor analogs.