title: Estimation of radiation dosimetry for68Ga-HBED-CC (PSMA-11) in patients with suspected recurrence of prostate cancer.
abstract: BACKGROUND
  This study was performed to estimate the human radiation dosimetry for [68Ga]Ga-HBED-CC (PSMA-11) (68Ga PSMA-11).
  
  
  METHODS
  Under an RDRC-approved research protocol, we evaluated the biodistribution and pharmacokinetics of68Ga PSMA-11 with serial PET imaging following intravenous administration to nine prostate cancer patients in whom clinical [11C]acetate PET/CT exams had been independently performed under Expanded Access IND 118,204. List-mode imaging was performed over the initial 0-10min post-injection with the pelvis in the field-of-view. Whole-body images were acquired, pelvis-to-head, at 15, 60, and 90-min post-injection. Additional images of the pelvis were acquired at 40-min and 115-min, and voided urine collected from each subject at 48-min and 120-min post-injection. Radiation dosimetry estimates were calculated from these data using the OLINDA software package.
  
  
  RESULTS
  Renal uptake was high and relatively invariant, ranging from 11% to 14% of the injected dose between 15 and 90-min post-injection. Radioactivity collected in the voided urine accounted for 14% of the injected dose over a period of 120-min. Lymph nodes and skeletal metastases suspicious for prostate cancer recurrence were detected in a greater number of patients using68Ga PSMA-11 than using11C-acetate.
  
  
  CONCLUSIONS
  Kidneys are the critical organ following68Ga PSMA-11 administration, receiving an estimated dose of 0.413mGy/MBq.
  
  
  CONCLUSIONS
  This study confirms that the kidneys will be the critical organ following intravenous administration of68Ga PSMA-11, and provided data consistent with the expectation that68Ga PSMA-11 will be superior to [11C]acetate for defining sites of recurrence in prostate cancer patients presenting with biochemical relapse.
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Green
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Jacob A
authors.initials: JA
authors.lastname: Eitel
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA. Electronic address: jwfletch@iupui.edu.
authors.forename: James W
authors.initials: JW
authors.lastname: Fletcher
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Carla J
authors.initials: CJ
authors.lastname: Mathias
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Tann
authors.affiliation: Department of Urology, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gardner
authors.affiliation: Department of Urology, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Michael O
authors.initials: MO
authors.lastname: Koch
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Wendy
authors.initials: W
authors.lastname: Territo
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Polson
authors.affiliation: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Gary D
authors.initials: GD
authors.lastname: Hutchins
mesh_terms: D004492:Edetic Acid / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D000072078:Positron Emission Tomography Computed Tomography; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging*; D011874:Radiometry; D012008:Recurrence
chemical_list: C075313:N,N'-bis(2-hydroxy-5-(ethylene-beta-carboxy)benzyl)ethylenediamine N,N'-diacetic acid; D004492:Edetic Acid
keywords: (68)Ga-DKFZ-PSMA-11; (68)Ga-HBED-CC (PSMA-11); Dosimetry; Glu-NH-CO-NH-Lys-(Ahx)-[(68)Ga(HBED-CC)]; PSMA-targeted PET/CT; Prostate cancer recurrence