Safety and tolerability of 68 Ga-NT-20.3, a radiopharmaceutical for targeting neurotensin receptors, in patients with pa

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Safety and tolerability of 68Ga-NT-20.3, a radiopharmaceutical for targeting neurotensin receptors, in patients with pancreatic ductal adenocarcinoma: the first in-human use Marina Hodolic 1,2 & Wen-Yu Wu 3 & Zhenyu Zhao 3 & Fei Yu 3 & Irene Virgolini 4 & Feng Wang 3 Received: 13 July 2020 / Accepted: 17 September 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract Introduction Over the last decades, multiple peptide receptors were recognized as potential diagnostic and therapeutic targets in nuclear medicine. 68Ga-NT-20.3 radiopharmaceutical has been developed for diagnosis of neurotensin receptors. High neurotensin receptor expression has been observed in pancreatic ductal adenocarcinoma as well as various malignancies. Until now, 68Ga-labelled NT ligand was successfully applied in in vitro as well as in animal model. Our study is the first in-human study on safety and tolerability of 68Ga-NT-20.3. Methods Subjects were intravenously injected with 2.5 MBq of 68Ga-DOTA-NT-20.3 per kilogramme of body weight, and series of PET images were acquired at 5–25 min, 25–45 min, 45–65 min, and 65–85 min after 68Ga-NT-20.3 injection. Vital parameters are as follows: systolic and diastolic blood pressure (mmHg), heart rate (heart beat/min), respiratory rate (number of breaths/min), ECG, and body temperature (°C) were checked before, immediately after, and 3 h after 68Ga-NT-20.3 injection. The organ-absorbed doses were calculated for the self-dose and cross-dose from each organ region using the OLINDA/EXM version 2.1 software. Results and conclusion The results from this small trial demonstrate that PET radiopharmaceutical 68Ga-NT-20.3 is safe and well tolerated. Keywords

68

Ga-NT-20.3 . Neurotensin . PET

Introduction The incidence of pancreatic cancer is increasing. Life expectancy of 5% at 5 years shows that prognosis for patients with pancreatic cancer has not improved over the past 20 years,

with still very similar values of incidence and mortality rates [1]. The major role of imaging modalities in management of patients with pancreatic neoplasms is to determine tumour size/tumour vessel involvement, to stage the disease, to assist

This article is part of the Topical Collection on Oncology - Digestive tract. * Marina Hodolic [email protected] Wen-Yu Wu [email protected]

Feng Wang [email protected] 1

Nuclear Medicine Research Department, IASON, Graz, Austria

2

Department of Nuclear Medicine, Faculty of Medicine and Dentistry, Palacký University Olomouc, Olomouc, Czech Republic

3

Department of Nuclear Medicine, Nanjing First Hospital, Nanjing Medical University, Nanjing, China

4

Department of Nuclear Medicine, Medical University of Innsbruck, Innsbruck, Austria

Zhenyu Zhao [email protected] Fei Yu [email protected] Irene Virgolini [email protected]

Eur J Nucl Med Mol Imaging

surgery, radiotherapy, and chemotherapy, and to monitor disease recurrence. As it “does not currently add much staging information in most patients with resectable d