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  • 1.
    Aerts, Joel
    et al.
    University of Liege, Belgium; University of Paris 07, France.
    Ballinger, James R.
    Guy's and St Thomas' Hospital, London, UK.
    Behe, Martin
    ETH PSI USZ Paul Scherrer Institute, Villigen-PSI, Switzerland.
    Decristoforo, Clemens
    Innsbruck Medical University, Austria.
    Elsinga, Philip H.
    University of Groningen, Netherlands.
    Faivre-Chauvet, Alain
    CHU Nantes, France.
    Mindt, Thomas L.
    University Hospital Basel, Switzerland.
    Kolenc Peitl, Petra
    University Medical Centre Ljubljana, Slovenia.
    Todde, Sergio C.
    University of Milano-Bicocca, Italy.
    Koziorowski, Jacek
    Linköping University, Department of Medical and Health Sciences, Division of Radiological Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics.
    Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective2014In: Journal of labelled compounds & radiopharmaceuticals, ISSN 0362-4803, E-ISSN 1099-1344, Vol. 57, no 10, p. 615-620Article in journal (Refereed)
    Abstract [en]

    This document is meant to complement Part B of the EANM Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals issued by the Radiopharmacy Committee of the European Association of Nuclear Medicine, covering small-scale in-house preparation of radiopharmaceuticals with automated modules. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals, which are not intended for commercial purposes or distribution.

  • 2.
    Bernhardsson, Magnus
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences.
    Sandberg, Olof
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences.
    Ressner, Marcus
    Linköping University, Department of Biomedical Engineering. Linköping University, Faculty of Science & Engineering. Linköping University, Center for Medical Image Science and Visualization (CMIV).
    Koziorowski, Jacek
    Linköping University, Department of Medical and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics. Linköping University, Faculty of Medicine and Health Sciences.
    Malmqvist, Jonas
    Linköping University, Department of Medical and Health Sciences, Division of Radiological Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Aspenberg, Per
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Orthopaedics in Linköping.
    Shining dead bone-cause for cautious interpretation of [F-18]NaF PET scans2018In: Acta Orthopaedica, ISSN 1745-3674, E-ISSN 1745-3682, Vol. 89, no 1, p. 124-127Article in journal (Refereed)
    Abstract [en]

    Background and purpose — [18F]Fluoride ([18F]NaF) PET scan is frequently used for estimation of bone healing rate and extent in cases of bone allografting and fracture healing. Some authors claim that [18F]NaF uptake is a measure of osteoblastic activity, calcium metabolism, or bone turnover. Based on the known affinity of fluoride to hydroxyapatite, we challenged this view.

    Methods — 10 male rats received crushed, frozen allogeneic cortical bone fragments in a pouch in the abdominal wall on the right side, and hydroxyapatite granules on left side. [18F]NaF was injected intravenously after 7 days. 60 minutes later, the rats were killed and [18F]NaF uptake was visualized in a PET/CT scanner. Specimens were retrieved for micro CT and histology.

    Results — MicroCT and histology showed no signs of new bone at the implant sites. Still, the implants showed a very high [18F]NaF uptake, on a par with the most actively growing and remodeling sites around the knee joint.

    Interpretation — [18F]NaF binds with high affinity to dead bone and calcium phosphate materials. Hence, an [18F]NaF PET/CT scan does not allow for sound conclusions about new bone ingrowth into bone allograft, healing activity in long bone shaft fractures with necrotic fragments, or remodeling around calcium phosphate coated prostheses

  • 3.
    Huang, Ya-Yao
    et al.
    PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.
    Taylor, Stephen
    Department of Nuclear Medicine, Royal Brisbane and Women’s Hospital, Herston, Australia.
    Koziorowski, Jacek
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics.
    Chang, Yu-Ning
    Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.
    Kao, Wei-Hua
    PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.
    Tzen, Kai-Yuan
    PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan; Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.
    Shiue, Chyng-Yann
    PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan; Molecular Imaging Center, National Taiwan University, Taipei, Taiwan; PET Center, Department of Nuclear Medicine, Tri-Service General Hospital, Taipei, Taiwan.
    A two‐center study for the quality control of [18F]FDG using FASTlab phosphate cassettes2016In: Annals of Nuclear Medicine, ISSN 0914-7187, E-ISSN 1864-6433, Vol. 30, no 8, p. 563-571Article in journal (Refereed)
    Abstract [en]

    Objective: The GE FASTlab radiosynthesis module is routinely used for the production of [18F]FDG, utilizing the commercially available phosphate cassettes. Because of the observation of a white precipitate in the product vial before the product expiry time, we re-examined the quality of the produced [18F]FDG solution.

    Methods: Phosphate buffered [18F]FDG solution was synthesized on the FASTlab and analyzed at both National Taiwan University Hospital (NTUH) of Taiwan and Royal Brisbane and Women’s Hospital (RBWH) of Australia. In addition to the standard product quality control (QC), the concentration of aluminum (Al3+) as probable cause of the precipitations in the [18F]FDG solution was analyzed by inductively coupled plasma mass spectrometry (ICP-MS at RBWH) and inductively coupled plasma optical emission spectrometry (ICP-OES at NTUH), and using three semi-quantitative methods at NTUH, Advantec® Alumi Check Test Strip, Quantofix® Aluminum Test Strip and MColortest™ Aluminum Test kit.

    Results: The precipitates were observed in the [18F]FDG solution within 24 (NTUH) and 6 (RBWH) hours after the end of synthesis in 38–100 % of the batches, dependent on the batch of the FASTlab cassettes. Addition of metal-free HCl(aq) to aliquots of [18F]FDG containing precipitate, followed by ICP-MS analysis revealed Al3+ concentrations of 70–80 ppm. Al3+ concentrations of 10–12 ppm were detected in [18F]FDG batches that did not show any precipitation. In contrast, less than 5 ppm of the residual Al3+ was detected by semi-quantitative methods in all batches.

    Conclusion: The US (USP), British (BP), European (EP) and Japanese (JP) pharmacopeias demand that [18F]FDG for injection should be clear and particulate free within the given shelf-life/expiration time. To avoid Al-phosphate precipitation within the product expiry time, FASTlab citrate cassettes, rather than phosphate cassettes, should be used for [18F]FDG production. Although testing for Al3+ is not listed in the [18F]FDG monographs of the USP, BP and EP, residual Al3+ levels should be considered in the interests of patient safety.

  • 4.
    Joshi, Sameer M.
    et al.
    CIC BiomaGUNE, Spain.
    de Cozar, Abel
    University of Basque Country, Spain; Ikerbasque, Spain; Centre Innovac Quim Avanzada ORFEO CINQA, Spain; DIPC, Spain.
    Gomez-Vallejo, Vanessa
    CIC BiomaGUNE, Spain.
    Koziorowski, Jacek
    Linköping University, Department of Medical and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics. Linköping University, Faculty of Medicine and Health Sciences.
    Llop, Jordi
    CIC BiomaGUNE, Spain.
    Cossio, Fernando P.
    University of Basque Country, Spain; Centre Innovac Quim Avanzada ORFEO CINQA, Spain.
    Synthesis of radiolabelled aryl azides from diazonium salts: experimental and computational results permit the identification of the preferred mechanism2015In: Chemical Communications, ISSN 1359-7345, E-ISSN 1364-548X, Vol. 51, no 43, p. 8954-8957Article in journal (Refereed)
    Abstract [en]

    Experimental and computational studies on the formation of aryl azides from the corresponding diazonium salts support a stepwise mechanism via acyclic zwitterionic intermediates. The low energy barriers associated with both transition structures are compatible with very fast and efficient processes, thus making this method suitable for the chemical synthesis of radiolabelled aryl azides.

  • 5.
    Koziorowski, Jacek
    et al.
    Linköping University, Department of Medical and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics. Linköping University, Faculty of Medicine and Health Sciences.
    Stanciu, Adina E.
    Institute Oncology Prof Dr Al Trestioreanu Bucharest, Romania.
    Gomez-Vallejo, Vanessa
    CIC biomaGUNE, Spain.
    Llop, Jordi
    CIC biomaGUNE, Spain.
    Radiolabeled Nanoparticles for Cancer Diagnosis and Therapy2017In: ANTI-CANCER AGENTS IN MEDICINAL CHEMISTRY, ISSN 1871-5206, Vol. 17, no 3, p. 333-354Article, review/survey (Refereed)
    Abstract [en]

    Cancer remains as one of the major causes of death worldwide. The emergence of nanotechnology has opened new avenues for the development of nanoparticle (NP)-based diagnostic and therapeutic tools. NPs of different chemical composition, size, shape and surface decoration can be prepared using a wide variety of synthetic strategies. Subsequent radiolabelling with positron or gamma emitters results in potential diagnostic agents which may offer improved selectivity and/or specificity for the target organ or tissue, enabling the acquisition of images with higher signal-to-contrast ratio. Incorporation of alpha or beta emitters leads to therapeutic agents with application in the field of radiotherapy. Here, we first describe the different labeling strategies reported so far for the incorporation of radionuclides into NPs. Recent advances in the use of nanoparticulate constructs both in the diagnostic and therapeutic arenas are then discussed and examples of their application are briefly discussed.

  • 6.
    Mihon, Mirela
    et al.
    University of Politehn Bucuresti, Romania; Horia Hulubei National Institute Phys and Nucl Engn, Romania.
    Stelian Tuta, Catalin
    Horia Hulubei National Institute Phys and Nucl Engn, Romania.
    Catrinel Ion, Alina
    University of Politehn Bucuresti, Romania.
    Koziorowski, Jacek
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics.
    Niculae, Dana
    Horia Hulubei National Institute Phys and Nucl Engn, Romania.
    Lavric, Vasile
    University of Politehn Bucuresti, Romania.
    Draganescu, Doina
    Horia Hulubei National Institute Phys and Nucl Engn, Romania; Carol Davila University of Medical and Pharm, Romania.
    INFLUENCE OF THE SEPARATION PARAMETERS APPLIED FOR DETERMINATION OF IMPURITIES FDG AND CLDG2017In: Farmacia, ISSN 0014-8237, E-ISSN 2065-0019, Vol. 65, no 1, p. 153-158Article in journal (Refereed)
    Abstract [en]

    2-fluoro-2-deoxy-D-glucose (FDG) and 2-chloro-2-deoxy-D-glucose (CIDG) are chemical impurities found in the 2-[F-18]fluoro-2-deoxy-D-glucose products (F-18-FDG). The objective of this study was to find the best condition for the separation of FDG and CIDG, evaluating different columns under various operating conditions. Chromatographic parameters such as column temperature, composition and flow rate of the mobile phase were the independent variables used in the optimization process. The optimized method was validated and validation results showed a good accuracy, repeatability and reproducibility.

  • 7.
    Taldone, Tony
    et al.
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Zatorska, Danuta
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Ochiana, Stefan O.
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Smith-Jones, Peter
    Mem Sloan Kettering Cancer Centre, NY 10065 USA; Stony Brook School Med, NY USA; Stony Brook School Med, NY USA.
    Koziorowski, Jacek
    Department of Radiology, Memorial Sloan Kettering Cancer Center, New York,NY, USA.
    Dunphy, Mark P.
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Zanzonico, Pat
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Bolaender, Alexander
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Lewis, Jason S.
    Mem Sloan Kettering Cancer Centre, NY 10065 USA; Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Larson, Steven M.
    Mem Sloan Kettering Cancer Centre, NY 10065 USA; Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Chiosis, Gabriela
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Vara Kishore Pillarsetty, Naga
    Mem Sloan Kettering Cancer Centre, NY 10065 USA.
    Radiosynthesis of the iodine-124 labeled Hsp90 inhibitor PU-H712016In: Journal of labelled compounds & radiopharmaceuticals, ISSN 0362-4803, E-ISSN 1099-1344, Vol. 59, no 3, p. 129-132Article in journal (Refereed)
    Abstract [en]

    Heat shock protein 90 (Hsp90) is an ATP dependent molecular chaperone protein whose function is critical for maintaining several key proteins involved in survival and proliferation of cancer cells. PU-H71 (1), is a potent purine-scaffold based ATP pocket binding Hsp90 inhibitor which has been shown to have potent activity in a broad range of in vivo cancer models and is currently in Phase I clinical trials in patients with advanced solid malignancies, lymphomas, and myeloproliferative neoplasms. In this report, we describe the radiosynthesis of [I-124]-PU-H71(5); this was synthesized from the corresponding Boc-protected stannane precursor 3 by iododestannylation with [I-124]-NaI using chloramine-T as an oxidant for 2min, followed by Boc deprotection with 6 N HCl at 50 degrees C for 30min to yield the final compound. The final product 5 was purified using HPLC and was isolated with an overall yield of 55 +/- 6% (n=6, isolated) from 3, and >98% purity and an average specific activity of 980mCi/mu mol. Our report sets the stage for the introduction of [I-124]-PU-H71 as a potential non-invasive probe for understanding biodistribution and pharmacokinetics of PU-H71 in living subjects using positron emission tomography imaging.

  • 8.
    Todde, S.
    et al.
    University of Milano-Bicocca, Tecnomed Foundation, Italy.
    Peitl, P. Kolenc
    Department of Nuclear Medicine, University Medical Centre Ljubljana, Slovenia.
    Elsinga, P.
    University Medical Center Groningen, University of Groningen, The Netherlands.
    Koziorowski, Jacek
    Linköping University, Department of Medical and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics. Linköping University, Faculty of Medicine and Health Sciences.
    Ferrari, V.
    GE Healthcare, Amersham, UK.
    Ocak, E. M.
    Faculty of Pharmacy, Department of Pharmaceutical Technology, Istanbul University, Istanbul Turkey.
    Hjelstuen, O.
    Institute for Energy Technology, Norway.
    Patt, M.
    Department for Nuclear Medicine, Radiochemistry, Leipzig, Germany.
    Mindt, T. L.
    Ludwig Boltzmann Institute Applied Diagnostics, General Hospital Vienna, Nuklearmedizin, Vienna, Austria; 10Department of Biomedical Imaging and Image Guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Vienna, Austria.
    Behe, M.
    Center for Radiopharmaceutical Sciences ETH-PSI-USZ Paul-Scherrer-Institute, Switzerland.
    Guidance on validation and qualification of processes and operations involving radiopharmaceuticals2017In: EJNMMI radiopharmacy and chemistry, ISSN 2365-421X, Vol. 2, no 1Article, review/survey (Refereed)
    Abstract [en]

    Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. This document is meant as an Appendix of Part B of the EANM "Guidelines on Good Radiopharmacy Practice (GRPP)" issued by the Radiopharmacy Committee of the EANM, covering the qualification and validation aspects related to the small-scale "in house" preparation of radiopharmaceuticals. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals which are not intended for commercial purposes or distribution.

  • 9.
    Todde, Sergio
    et al.
    University of Milano Bicocca, Italy.
    Windhorst, Albert D.
    Vrije University of Amsterdam, Netherlands.
    Behe, Martin
    ETH PSI USZ, Switzerland.
    Bormans, Guy
    Katholieke University of Leuven, Belgium.
    Decristoforo, Clemens
    Medical University of Innsbruck, Austria.
    Faivre-Chauvet, Alain
    CHU Nantes, France.
    Ferrari, Valentina
    GE Healthcare, England.
    Gee, Antony D.
    Kings Coll London, England.
    Gulyas, Balazs
    Karolinska Institute, Sweden.
    Halldin, Christer
    Karolinska Institute, Sweden.
    Kolenc Peitl, Petra
    University of Medical Centre Ljubljana, Slovenia.
    Koziorowski, Jacek
    Linköping University, Department of Medical and Health Sciences, Division of Radiological Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Radiation Physics.
    Mindt, Thomas L.
    University of Basel Hospital, Switzerland.
    Sollini, Martina
    Arcispedale Santa Maria Nuova, Italy.
    Vercouillie, Johnny
    University of Tours, France.
    Ballinger, James R.
    Guys and St Thomas Hospital, England.
    Elsinga, Philip H.
    University of Groningen, Netherlands.
    EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)2014In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 41, no 11, p. 2175-2185Article in journal (Refereed)
    Abstract [en]

    The preparation of an Investigational Medicinal Product Dossier (IMPD) for a radiopharmaceutical to be used in a clinical trial is a challenging proposition for radiopharmaceutical scientists working in small-scale radiopharmacies. In addition to the vast quantity of information to be assembled, the structure of a standard IMPD is not well suited to the special characteristics of radiopharmaceuticals. This guideline aims to take radiopharmaceutical scientists through the practicalities of preparing an IMPD, in particular giving advice where the standard format is not suitable. Examples of generic IMPDs for three classes of radiopharmaceuticals are given: a small molecule, a kit-based diagnostic test and a therapeutic radiopharmaceutical.

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