title: Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.
abstract: 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.
  
  
  CONCLUSIONS
  Human normal-organ kinetics, radiation dosimetry, clinical safety, and imaging efficacy provide compelling evidence for the use of high-specific-activity (123)I-iobenguane.
authors.affiliation: Department of Radiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Bennett B
authors.initials: BB
authors.lastname: Chin
authors.forename: James F
authors.initials: JF
authors.lastname: Kronauge
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Femia
authors.forename: Jianqing
authors.initials: J
authors.lastname: Chen
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Maresca
authors.forename: Shawn
authors.initials: S
authors.lastname: Hillier
authors.forename: Neil A
authors.initials: NA
authors.lastname: Petry
authors.forename: Olga G
authors.initials: OG
authors.lastname: James
authors.forename: Jorge D
authors.initials: JD
authors.lastname: Oldan
authors.forename: Thomas
authors.initials: T
authors.lastname: Armor
authors.forename: James B
authors.initials: JB
authors.lastname: Stubbs
authors.forename: Michael G
authors.initials: MG
authors.lastname: Stabin
authors.forename: John W
authors.initials: JW
authors.lastname: Babich
mesh_terms: D019797:3-Iodobenzylguanidine / Q000737:chemistry / Q000493:pharmacokinetics*; D000328:Adult; D003287:Contrast Media / Q000493:pharmacokinetics*; D004562:Electrocardiography; D005260:Female; D064368:Healthy Volunteers; D006321:Heart / Q000000981:diagnostic imaging; D006801:Humans; D007457:Iodine Radioisotopes / Q000493:pharmacokinetics*; D008297:Male; D008482:Mediastinum / Q000000981:diagnostic imaging; D008875:Middle Aged; D019047:Phantoms, Imaging; D011829:Radiation Dosage; D011857:Radiographic Image Interpretation, Computer-Assisted; D011874:Radiometry; D019275:Radiopharmaceuticals; D013997:Time Factors; D014018:Tissue Distribution; D015899:Tomography, Emission-Computed, Single-Photon; D051598:Whole Body Imaging
chemical_list: D003287:Contrast Media; D007457:Iodine Radioisotopes; D019275:Radiopharmaceuticals; D019797:3-Iodobenzylguanidine
keywords: MIBG; high specific activity; human distribution; human dosimetry; iobenguane 123I