Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors

Our purpose was to evaluate the safety and efficacy of Ga-68-DOTATATE PET/CT compared with In-111-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors. Methods: Ga-68-DOTATATE PET/CT and In-111-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 Ga-68-DOTATATE injection. Added value was determined by changes in treatment plan when Ga-68-DOTATATE PET/CT results were added to all prior imaging, including 111In-pentetreotide. Interobserver reproducibility of Ga-68-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters. Results: Ga-68-DOTATATE PET/CT and In-111-pentetreotide scans were significantly different in impact on treatment (P < 0.001). Ga-68-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. Ga-68-DOTATATE PET/CT correctly identified 3 patients for peptide receptor radiotherapy incorrectly classified by In-111-pentetreotide. Conclusion: Ga-68-DOTATATE PET/CT was equivalent or superior to In-111-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. Ga-68-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with In-111-pentetreotide, Ga-68-DOTATATE imaging should be used instead of In-111-pentetreotide imaging where available.