In this prospective referring-physician-based survey, we investigated the definite clinical impact of 68 Ga-DOTATATE PET/CT on managing patients with neuroendocrine tumors (NETs). Methods: We prospectively studied 130 patients with 68 Ga-DOTATATE PET/ CT referred for initial or subsequent management decisions (NCT02174679). Referring physicians completed one questionnaire before the scan (Q1) to indicate the treatment plan without PET/CT information, one immediately after review of the imaging report to denote intended management changes (Q2), and one 6 mo later (Q3) to verify whether intended changes were in fact implemented. To further validate the Q3 responses, a systematic electronic chart review was conducted. Results: All 3 questionnaires were completed by referring physicians for 96 of 130 patients (74%). 68 Ga-DOTATATE PET/CT resulted in intended management changes (Q2) in 48 of 96 patients (50%). These changes were finally implemented (Q3) in 36 of 48 patients (75%). Q3 responses were confirmed in all patients with an available electronic chart (36/96; 38%). Conclusion: This prospective study confirmed a significant impact of 68 Ga-DOTATATE PET/CT on the intended management of patients with NETs (50% of changes) and notably demonstrated a high implementation rate (75%) of these intended management changes.Key Words: neuroendocrine tumors; somatostatin receptor; PET/ CT; DOTATATE; impact on implemented management J Nucl Med 2017; 58:1793 58: -1796 58: DOI: 10.2967 Somat ostatin receptor PET/CT imaging using 68 Ga-DOTATATE is reproducible (1) and affects patient management (2). Recent retrospective analyses suggest that intended management changes are in fact implemented (2). We recently reported intended management changes in 60% of patients with NET after 68 Ga-DOTATATE PET/CT imaging (3). In this subsequent prospective study, we investigated the definite clinical impact of 68 Ga-DOTATATE PET/CT on NET patient management by comparing intended with actually implemented treatment strategies.
MATERIALS AND METHODS
Registration and AuthorizationAfter submitting an initial investigational new drug application for 100 patients (NCT01873248) (3), we obtained an expanded-access investigational new drug number (122332; NCT02174679) from the Food and Drug Administration that allowed us to study an additional 300 patients. We enrolled 130 patients with suspected or histologically proven NETs who were referred to the University of California, Los Angeles, for a 68 Ga-DOTATATE PET/CT scan. That institution's review board approved the protocol, the informed consent forms, the participant information forms, and the prospective referring physician questionnaires (approval 12-001920). All patients provided written informed consent.
Patient Preparation and Image AcquisitionA standard 68 Ga-DOTATATE PET/CT protocol was used (3). The median injected dose of 68 Ga-DOTATATE was 185 MBq (5 mCi) (range, 85.1-210.9 MBq [2.3-5.7 mCi]). The median tracer uptake time was 61 min (range, 46-97 min). Images were acquired using a Bi...