Karin Michaelsen Nielsen

A comprehensive safety evaluation of 68Ga-PSMA-11 PET/CT in prostate cancer the results of 2 prospective, multicenter trials

Purpose The aim of this study was to evaluate the clinical safety profile of the 68Ga-PSMA-11 ligand for PET/CT imaging in prospective clinical trials. Methods Eighty-eight patients with newly diagnosed or recurrent prostate cancer participated in 2 prospective trials. Safety reporting was identical in the 2 trials. The 68Ga-PSMA-11 ligand was administered as 2 MBq/kg body weight (mean, 9.2 &mgr;g, 9.7 nmol). The reporting of clinical adverse events (AEs) and the measurement of blood pressure (BP) and heart rate (HR) were performed prior to injection (baseline); immediately after injection of 68Ga-PSMA-11 (postinjection); at 1, 10, and 60 minutes after injection; and after acquisition of the PET/CT scan (postscan). All hemodynamic assessments were performed in the supine position, except for the postscan measurement (sitting). The patients were interviewed regarding any AEs at baseline, postinjection, or postscan. In addition, the patients were instructed to report any AEs during the investigation and to contact the investigator if AEs occurred during the rest of the day. Adverse events were classified as mild, moderate, or severe by the patients and categorized by the investigator using the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. Results There were no reported clinical AEs. There were significant decreases in systolic BP (P < 0.001) and HR (P < 0.001) over time. In comparison, the diastolic BP increased significantly (P < 0.001). After removal of the last observation (supine position), there was no time-dependent change in systolic or diastolic BP, but the significant change in HR remained. The mean changes over the entire observation period were minimal (systolic BP, −6 to 5 mm Hg; diastolic BP, −2 to 3 mm Hg; HR, decrease of 5 beats/min). No patients developed hypotension. Fifty-five patients presented with hypertension at baseline, which increased by 1 CTCAE grade in 15 patients and by 2 grades in 2 patients. A large number of cases of asymptomatic (grade 1) bradycardia were observed, primarily in patients with preexisting bradycardia. One patient developed transient grade 1 tachycardia. No patients required medical intervention for cardiovascular perturbations. Conclusions 68Ga-PSMA-11 PET/CT was very well tolerated. We consider 68Ga-PSMA-11 to be safe for human application.

Fast and simple one-step preparation of ⁶⁸Ga citrate for routine clinical PET

The imaging of infectious and inflammatory diseases using gallium-67 (67Ga) citrate scintigraphy has been a well-established diagnostic tool for decades. In recent times, interest has focused on PET using the short-lived positron emitting radioisotope 68Ga. 68Ga is not only more readily available, it also provides better quality images whose high resolution permits quantitative analyses, thus improving the management of patients suffering from infections or inflammation. The purpose of our study was to develop a fast and reliable synthesis protocol for the preparation of 68Ga citrate under good manufacturing practice aspects without the use of organic solvents. A commercially available synthesis module was used to perform 10 syntheses with an average yield of 768±31 MBq (mean±SD) within 10 min; 92.04±1.23% of the radioactivity was located in the product vial, and the rest on the cation exchange cartridge (7.48±1.23%) and in the waste vial (0.47±0.28%). The radiochemical purity of the product determined by instant thin-layer chromatography was greater than 99%. The products have been proven to be sterile and pyrogen-free. Variations were made in several critical synthesis parameters, and the results are presented herein. By eliminating the use of organic solvents, the previously required quality control testing of the final product by gas chromatography can be abandoned. This novel, high-yielding method allows for a more efficient synthesis of 68Ga citrate with both shorter production time and high radiochemical purity.

Design of a multi-functional automated 68Ga-synthesis program

M. Tamulaitiene, M. Jaramaviciene, J. Jaramavicius, V. Alekna. Faculty of Medicine of Vilnius University, Vilnius, Lithuania Objectives: To analyze the methods of treatment and outcome of hip fractures in Lithuania. Methods: This population-based retrospective study was performed collecting the data from all orthopaedic inpatient departments in Lithuania. The records of subjects, who were hospitalized because of primary hip fracture (ICD-10 codes S72.0, S72.1 and S72.2) at the age over 40 years in 2010, were examined. Methods of treatment were conservative and surgical, while the latter was divided into fixation by screws, plate or intramedullary nail (IN), and total hip arthroplasty (TA). The outcomes included death, transfer to another department, discharge home or long-term hospital, and rehabilitation. Results: In 2010, 2626 hip fractures occurred in Lithuania. The most common method used was osteosynthesis: fixation by plate accounted for 41.4%, screw – 21.1%), and by IN – in 3.4% of cases. TAwas used in 25.9% and conservative treatment – in 8.1% of patients. After fixation by screws, plates and IN, the majority of patients were discharged home (42.5%, 35.8% and 37.8%, respectively) or to long-term care hospital (24.5%, 22% and 32.2%, respectively). Otherwise, after TA, 70.1% of patients underwent rehabilitation. Among patients treated conservatively, 39.7% were transferred to another department, ant their mortality rate was highest (4.2%). Number of deaths was lowest after treatment with screws (0.7%). Conclusion: In 2010, in Lithuania, the majority of patients with hip fracture were treated with osteosynthesis using the external fixation. Rehabilitation was more often outcome of treatment using total hip arthroplasty, as compared to osteosynthesis.