title: Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors.
abstract: Our purpose was to evaluate the safety and efficacy of (68)Ga-DOTATATE PET/CT compared with (111)In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors.
  
  
  
  (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were obtained for 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic neuroendocrine tumors. Safety and toxicity were measured by comparing vital signs, serum chemistry values, or acquisition-related medical complications before and after (68)Ga-DOTATATE injection. Added value was determined by changes in treatment plan when (68)Ga-DOTATATE PET/CT results were added to all prior imaging, including (111)In-pentetreotide. Interobserver reproducibility of (68)Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters.
  
  
  
  (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were significantly different in impact on treatment (P < 0.001). (68)Ga-DOTATATE PET/CT combined with CT or liver MRI changed care in 28 of 78 (36%) patients. Interobserver agreement between blinded and nonblinded interpreters was high. No participant had a trial-related event requiring treatment. Mild, transient events were tachycardia in 1, alanine transaminase elevation in 1, and hyperglycemia in 2 participants. No clinically significant arrhythmias occurred. (68)Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by (111)In-pentetreotide.
  
  
  
  (68)Ga-DOTATATE PET/CT was equivalent or superior to (111)In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. (68)Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with (111)In-pentetreotide, (68)Ga-DOTATATE imaging should be used instead of (111)In-pentetreotide imaging where available.
authors.affiliation: Veterans Affairs Hospital, Tennessee Valley VA Healthcare System, Nashville, Tennessee Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Deppen
authors.affiliation: Rocky Mountain Cancer Centers, Denver, Colorado.
authors.forename: Eric
authors.initials: E
authors.lastname: Liu
authors.affiliation: Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Blume
authors.affiliation: Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Clanton
authors.affiliation: Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Chanjuan
authors.initials: C
authors.lastname: Shi
authors.affiliation: Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Jones-Jackson
authors.affiliation: Oregon Medical Group, Springfield, Oregon.
authors.forename: Vipul
authors.initials: V
authors.lastname: Lakhani
authors.affiliation: THERANOSTICS Center for Molecular Radiotherapy and Molecular Imaging (PET/CT), ENETS Center of Excellence, Zentralklinik Bad Berka, Bad Berka, Germany.
authors.forename: Richard P
authors.initials: RP
authors.lastname: Baum
authors.affiliation: Vanderbilt-Ingram Cancer Center, Nashville, Tennessee; and.
authors.forename: Jordan
authors.initials: J
authors.lastname: Berlin
authors.affiliation: Veterans Affairs Hospital, Tennessee Valley VA Healthcare System, Nashville, Tennessee Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Gary T
authors.initials: GT
authors.lastname: Smith
authors.affiliation: Department of Radiology, University of Iowa, Iowa City, Iowa.
authors.forename: Michael
authors.initials: M
authors.lastname: Graham
authors.affiliation: Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Martin P
authors.initials: MP
authors.lastname: Sandler
authors.affiliation: Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Dominique
authors.initials: D
authors.lastname: Delbeke
authors.affiliation: Veterans Affairs Hospital, Tennessee Valley VA Healthcare System, Nashville, Tennessee Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee Vanderbilt-Ingram Cancer Center, Nashville, Tennessee; and ronald.walker@vanderbilt.edu.
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Walker
mesh_terms: D005260:Female; D006801:Humans; D007205:Indium Radioisotopes; D007414:Intestinal Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018358:Neuroendocrine Tumors / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*; D015588:Observer Variation; D009942:Organometallic Compounds / Q000009:adverse effects*; D010190:Pancreatic Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*; D000072078:Positron Emission Tomography Computed Tomography / Q000009:adverse effects*; D012449:Safety; D013004:Somatostatin / Q000009:adverse effects / Q000031:analogs & derivatives; D013274:Stomach Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*
chemical_list: D007205:Indium Radioisotopes; D009942:Organometallic Compounds; D013004:Somatostatin; C513399:gallium Ga 68 dotatate; C081788:pentetreotide
keywords: 111In-pentetreotide; 68Ga-DOTATATE; carcinoid; neuroendocrine; toxicity