title: Preclinical Study of68Ga-DOTATOC: Biodistribution Assessment in Syrian Rats and Evaluation of Absorbed Dose in Human Organs.
abstract: OBJECTIVE
  Gallium-68 DOTA-DPhe1-Tyr3-Octreotide (68Ga-DOTATOC) has been applied by several European centers for the treatment of a variety of human malignancies. Nevertheless, definitive dosimetric data are yet unavailable. According to the Society of Nuclear Medicine and Molecular Imaging, researchers are investigating the safety and efficacy of this radiotracer to meet Food and Drug Administration requirements. The aim of this study was to introduce the optimized procedure for68Ga-DOTATOC preparation, using a novel germanium-68 (68Ge)/68Ga generator in Iran and evaluate the absorbed doses in numerous organs with high accuracy.
  
  
  METHODS
  The optimized conditions for preparing the radiolabeled complex were determined via several experiments by changing the ligand concentration, pH, temperature and incubation time. Radiochemical purity of the complex was assessed, using high-performance liquid chromatography and instant thin-layer chromatography. The absorbed dose of human organs was evaluated, based on biodistribution studies on Syrian rats via Radiation Absorbed Dose Assessment Resource Method.
  
  
  RESULTS
  68Ga-DOTATOC was prepared with radiochemical purity of >98% and specific activity of 39.6 MBq/nmol. The complex demonstrated great stability at room temperature and in human serum at 37°C at least two hours after preparation. Significant uptake was observed in somatostatin receptor-positive tissues such as pancreatic and adrenal tissues (12.83 %ID/g and 0.91 %ID/g, respectively). Dose estimations in human organs showed that the pancreas, kidneys and adrenal glands received the maximum absorbed doses (0.105, 0.074 and 0.010 mGy/MBq, respectively). Also, the effective absorbed dose was estimated at 0.026 mSv/MBq for68Ga-DOTATOC.
  
  
  CONCLUSIONS
  The obtained results showed that68Ga-DOTATOC can be considered as an effective agent for clinical PET imaging in Iran.
authors.affiliation: Department of Chemistry, University of Zanjan, Zanjan, Iran.
authors.forename: Mojdeh
authors.initials: M
authors.lastname: Naderi
authors.affiliation: Nuclear Science and Technology Research Institute (NSTRI), Tehran, Iran.
authors.forename: Samaneh
authors.initials: S
authors.lastname: Zolghadri
authors.affiliation: Nuclear Science and Technology Research Institute (NSTRI), Tehran, Iran.
authors.forename: Hassan
authors.initials: H
authors.lastname: Yousefnia
authors.affiliation: Department of Chemistry, University of Zanjan, Zanjan, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Ramazani
authors.affiliation: Nuclear Science and Technology Research Institute (NSTRI), Tehran, Iran.
authors.forename: Amir Reza
authors.initials: AR
authors.lastname: Jalilian
keywords: Ga-68; Internal Dosimetry; Octreotide; Somatostatin