PT - JOURNAL ARTICLE AU - Stephen A. Deppen AU - Eric Liu AU - Jeffrey D. Blume AU - Jeffrey Clanton AU - Chanjuan Shi AU - Laurie B. Jones-Jackson AU - Vipul Lakhani AU - Richard P. Baum AU - Jordan Berlin AU - Gary T. Smith AU - Michael Graham AU - Martin P. Sandler AU - Dominique Delbeke AU - Ronald C. Walker TI - Safety and Efficacy of <sup>68</sup>Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors AID - 10.2967/jnumed.115.163865 DP - 2016 May 01 TA - Journal of Nuclear Medicine PG - 708--714 VI - 57 IP - 5 4099 - http://jnm.snmjournals.org/content/57/5/708.short 4100 - http://jnm.snmjournals.org/content/57/5/708.full SO - J Nucl Med2016 May 01; 57 AB - Our purpose was to evaluate the safety and efficacy of 68Ga-DOTATATE PET/CT compared with 111In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors. Methods: 68Ga-DOTATATE PET/CT and 111In-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 68Ga-DOTATATE injection. Added value was determined by changes in treatment plan when 68Ga-DOTATATE PET/CT results were added to all prior imaging, including 111In-pentetreotide. Interobserver reproducibility of 68Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters. Results: 68Ga-DOTATATE PET/CT and 111In-pentetreotide scans were significantly different in impact on treatment (P &lt; 0.001). 68Ga-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. 68Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by 111In-pentetreotide. Conclusion: 68Ga-DOTATATE PET/CT was equivalent or superior to 111In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. 68Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with 111In-pentetreotide, 68Ga-DOTATATE imaging should be used instead of 111In-pentetreotide imaging where available.