Most of the Intended Management Changes After ⁶⁸Ga-DOTATATE PET/CT Are Implemented

Abstract

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...

Impact of 68Ga-PSMA-11 PET/CT on the Management of Prostate Cancer Patients with Biochemical Recurrence

“…A significant impact of any diagnostic test on management suggests value for patients and is a prerequisite for widespread acceptance (7). However, one concern about studies using intended management changes as an endpoint is that these changes may not be implemented (8)(9)(10)(11). The implemented management reflects the true impact of an index test (8,9).…”

“…However, one concern about studies using intended management changes as an endpoint is that these changes may not be implemented (8)(9)(10)(11). The implemented management reflects the true impact of an index test (8,9). In fact, implemented management changes are the most reliable source for cost or cost-effectiveness analyses (8,21,22).…”

“…Often, this impact has been estimated from survey information after the index test information becomes available to treating physicians (7). However, intended management early after imaging results become available does not necessarily translate into implemented management (8)(9)(10)(11). To our knowledge, the rate of implemented management changes related to 68 Ga-PSMA-11 PET/CT has not been determined prospectively in patients with BCR.…”

(Radio)Theranostic Patient Management in Oncology Exemplified by Neuroendocrine Neoplasms, Prostate Cancer, and Breast Cancer

“…The meta-analysis of clinical studies demonstrated that [ 68 Ga]Ga-SST/PET-CT was vital for patient management leading to the regimen change in more than one third of patients (16%-71%) [109]. The treatment regimen was changed for 60% [110] and 50% [111] of the patients after [ 68 Ga]Ga-SST/PET-CT. In the patient sub-group re-evaluated for recurrence, the treatment management was changed after [ 68 Ga]Ga-SST/PET-CT in up to 25% of the patients [44].…”

“…However, the development of the respective radiopharmaceuticals is not always possible to achieve in practice. Metal radionuclides offer an advantage in terms of similarities in labelling chemistry, e.g., 68 Ga(III), 111 In(III), and 177 Lu(III), while providing variation in the radiation mode relevant for both diagnostic imaging (PET, SPECT) and endoradiotherapy. Moreover, 68 Ga(III), 111 In(III), and 177 Lu(III) can use the same chelator (DOTA) thus introducing the least possible difference in molecular structure and consequently specific target, e.g., receptor, binding properties.…”