2024-03-29T14:15:04Z
https://zenodo.org/oai2d
oai:zenodo.org:6607408
2022-06-03T01:50:32Z
user-medical_radionuclides_eu
user-eu
Cocolios, Thomas Elias
Dooms, Lucas
Ferrari, Piero
Payne, Oliver
Bernerd, Cyril
2022-05-13
<p>Density Functional Theory (DFT) calculations have been performed on simple Ti containing molecules, namely TiF, TiF<sub>2</sub>, TiF<sub>3</sub>, and TiF<sub>4</sub>, to establish the methodology (benchmark of the appropriate level of theory) and determine basic properties of these simple molecules, such as geometry, vibration frequencies, and binding to Ar atoms for clusterization (at room temperature and at 15 K). The frequencies identified are in the far infrared and thus are not practical for laser-based Fourier Transform Infrared (FTIR) spectroscopy.<br>
This method is then applied on more complex molecules, namely Ti[OEt]<sub>4</sub> and Ti[OPr]<sub>4</sub>, which have been identified within PRISMAP as potential candidates for enrichment applications. Preliminary results reproduce the experimental spectrum known for Ti[OEt]<sub>4</sub> and identify at which wavelength range the vibrational modes that are sensitive to the Ti isotope are located. This suggests that more complex molecules might not provide better separation than the simple TiF<sub>x</sub> molecules.</p>
Those results are preliminary. More extended calculations are being performed and shall be presented at the EMIS 2022 Conference in South Korea, Oct 2022.
https://doi.org/10.5281/zenodo.6607408
oai:zenodo.org:6607408
eng
Zenodo
https://zenodo.org/communities/medical_radionuclides_eu
https://zenodo.org/communities/eu
https://doi.org/10.5281/zenodo.6607407
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
Density functional theory
Clusters
DFT calculations for Ca and Ti containing molecules
info:eu-repo/semantics/report
oai:zenodo.org:10091918
2023-11-10T16:52:30Z
user-medical_radionuclides_eu
Cocolios, Thomas Elias
Duchemin, Charlotte
Mamis, Edgars
Stora, Thierry
2023-11-09
<p>According to the PRISMAP Description of Action, D10.6 is dedicated to the "Synthesis of the appropriate molecular precursors containing Ca and Ti and the related FTIR spectra measurements", towards the application of laser-enhanced isotopically selective condensation for the enrichment of Ca and Ti radionuclides.</p><p>As calcium hexafluoroacetylacetonate (C10H2CaF12O4) is commercially available, it has been procured externally for this purpose and characterised towards its planned use.</p><p>Gas-phase infrared spectroscopy was employed to investigate the vibrational modes of calcium hexafluoroacetylacetonate (C10H2CaF12O4) in the wide wavenumber range from 550 to 1700 cm-1. The measured spectrum agrees well with previous density functional theory calculations, allowing a targeted laser excitation within PRISMAP at 490 cm-1, in order to resonantly excite a Ca isotope sensitive vibration.</p><p>This demonstrates that this commercially available compound is appropriate for the sought-out application and that dedicated synthesis is thus not required.</p><p>A similar approach may now be followed for Ti-containing molecules, where we need first to identify a suitable stable molecule, then perform the associated DFT calculations, perform the synthesis if no commercial compound can be identified, and finally verify those with infrared light spectroscopy.</p>
https://doi.org/10.5281/zenodo.10091918
oai:zenodo.org:10091918
eng
Zenodo
https://zenodo.org/communities/medical_radionuclides_eu
https://doi.org/10.5281/zenodo.10091917
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
PRISMAP Deliverable D10.6 - Report on precursor synthesis and related infrared spectroscopy measurements
info:eu-repo/semantics/report
oai:zenodo.org:6599181
2022-06-01T01:50:52Z
user-medical_radionuclides_eu
user-eu
Clemens Decristoforo
Sason Feldkamp Hayashi
Cecile Bordeau
Ferid Haddad
David Viertl
Claire Deville
Clive Naidoo
Kristina Søborg Pedersen
Mikael Jensen
Ulli Köster
João Galamba Correia
Lurdes Gano
Frank Bruchertseifer
Kristof Baete
Renata Mikolajczak
Sean Collins
Susanne Geistlich
Nick van der Meulen
Bernard Ponsard
Michiel Van de Voorde
Monica Campillos
2022-05-31
<p>Radiopharmaceuticals are considered Medicinal Products, thereby they must be prepared and applied within the regulated area of pharmaceuticals. This includes radionuclides, which have seen extraordinary advancements in research and development over the last decade in regards to theranostics. The governing EU directives and regulations, including regulatory guidance, cannot keep pace with this development. PRISMAP, the European Medical Radionuclide Program, brings together key nuclear research centres and leading clinical translational research facilities across Europe to provide a sustainable source of high purity grade new radionuclides for the starting research community. One of PRISMAP`s paramount aims is to standardise and harmonise research and development activities with novel radionuclides to cope with pharmaceutical regulatory requirements and provide guidance for clinical translation. The PRISMAP workshop: “Radionuclide Production to Nuclear Medicine Clinical Applications: Regulatory Standards and Harmonisation of Quality and Safety”, held in February 2022, provided the basis for this document, which gives guidance for the early phase clinical research with novel radionuclides. It describes the current standards and a harmonised view of the European regulatory framework. The document complements the existing regulatory framework and is not considered legally binding.<br>
Six chapters cover different aspects in radiopharmaceutical development. Each chapter includes dedicated guidelines and guidance documents from regulatory authorities and professional organisations, as well as references to scientific publications on the respective topic.<br>
An introduction of PRISMAP and the project scope is followed by a definition of terms and nomenclature for specification of novel radionuclides within PRISMAP. The following chapter focuses on the production of radionuclides and implementation of GMP in the radiopharmaceutical development process. It provides relevant definitions and gives recommendations where GMP compliant processes should be introduced in the production of novel radionuclides. Guidance for controls of radionuclides including starting materials, process validation, in-process controls, chemical precursors and production of radiopharmaceuticals are briefly addressed. The subsequent chapter covers quality specifications and quality control. It includes details on relevant European Pharmacopoeia texts and guidance for compliance, summarises other regulatory texts from the EMA and ICH, giving general considerations on specifications and specific guidance for validation of analytical methods. It provides definitions on drug substance and drug product and addresses all relevant specific quality criteria for novel radionuclides. The next chapter deals with metrology and medical physics aspects in clinical translation. The relation to the Basic Safety Standards of the Council Directive 2013/59/Euratom is described, which includes aspects of therapy planning and dosimetry for novel radionuclides. Standardisation in relation to traceability is addressed in a dedicated part on Metrology. The role of Medical Physics in the context of standardisation and harmonisation of the clinical use of novel radionuclides for imaging equipment, image acquisition, processing parameters, and quality control implementation of new technologies is summarised.<br>
The final chapter covers Non-Clinical Safety and Pharmacology aspects and provides an overview of the current guidance documents to assess preclinical dosimetry, toxicity (new EMA guideline specific for radiopharmaceuticals), and pharmacology of radiopharmaceuticals, which are developed with the aim to be used in human clinical trials. Recent specific guidance documents on this topic, particularly from the IAEA are summarised and included.<br>
This guidance document serves as an essential and comprehensive guide for radionuclide producers, radiopharmaceutical translational scientists, clinical and hospital based radiopharmaceutical development researchers through the complex jungle of pharmaceutical regulations and guidelines. It provides a harmonised view to standardise data required for clinical translation of novel radionuclides.</p>
https://doi.org/10.5281/zenodo.6599181
oai:zenodo.org:6599181
eng
Zenodo
https://zenodo.org/communities/medical_radionuclides_eu
https://zenodo.org/communities/eu
https://doi.org/10.5281/zenodo.6599180
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
PRISMAP, radionuclides, pharmaceutical, standardization and harmonization
Standards for clinical translation
info:eu-repo/semantics/report
oai:zenodo.org:8247129
2023-08-18T14:44:44Z
user-medical_radionuclides_eu
user-eu
Sean Collins
2023-08-14
<p>Nuclear decay data are fundamental constants of a radionuclide’s decay process and are unique to that radionuclide. Nuclear decay data have been identified as being of importance to a wide range of activities in nuclear medicine, from the production of radionuclides to their use in nuclear medicine clinics. Accurate and precise data on nuclear decay is therefore necessary to ensure confidence in all activities undertaken throughout the process of using radiopharmaceutical products.</p>
<p>This report provides a review of the status of the nuclear decay data of the diagnostic or therapeutic radionuclides in the PRISMAP catalogue available at the start of the project in May 2021. There were eighteen original radionuclides available at the commencement of the project, which were identified as Sc-44, Sc-47, Cu-64, Cu-67, Ag-111, La-135, Tb-149, Tb-152, Tb-155, Tb-161, Er-165, Ho-166, Er-169, Yb-175, Pt-195m, Bi-213, At-211 and Ac-225. This review does not include a review of the radionuclides Dy-166 and Tm-165 that are used as generators to produce Ho-166 and Er-165 and has focused on these progenies instead. Whilst PRISMAP has extended their radionuclide catalogue since the initiation of the project to now encompass a total of twenty-six radionuclides at the time of publishing this report, these additional radionuclides have not been covered by this review. These may be included in a future review.</p>
<p>A summary of the current state of nuclear decay data of the initial eighteen radionuclides have been covered using the latest evaluations published by the Nuclear Data Sheets or the Decay Data Evaluation Project. Where recent studies have been published since the last evaluation a comparison to these new values have been included. Based on these reviews’ recommendations, where the current literature is lacking or there is room for improvement, new nuclear decay data studies are needed or have been proposed.</p>
https://doi.org/10.5281/zenodo.8247129
oai:zenodo.org:8247129
eng
Zenodo
https://zenodo.org/communities/medical_radionuclides_eu
https://zenodo.org/communities/eu
https://doi.org/10.5281/zenodo.8247128
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
Nuclear Decay Data
Half-life
Nuclear Medicine
Gamma-ray emission intensities
PRISMAP
Nuclear data for day-1 radionuclides
info:eu-repo/semantics/report
oai:zenodo.org:6606494
2022-06-02T15:48:25Z
user-medical_radionuclides_eu
user-eu
Jensen, Mikael
Naidoo, Clive
Bertreix, Philippe
Frosio, Thomas
Viertel, David
Köster, Ulli
Cocolios, Thomas Eias
2022-06-02
<p>This report is the first public output from the PRISMAP work package 9 (WP9, transport and logistics). The report describes in outline the existing rules and means of transport (primarily air and road) and how these rules and their implementation induce important constraints on the optimal distribution of novel radionuclides within the network. Based on input from the project partners and the analysis of the most urgent transportation needs arising from the first round of user projects, the report describes important bottlenecks for the efficient and reliable transport of novel radionuclides.</p>
https://doi.org/10.5281/zenodo.6606494
oai:zenodo.org:6606494
eng
Zenodo
https://zenodo.org/communities/medical_radionuclides_eu
https://zenodo.org/communities/eu
https://doi.org/10.5281/zenodo.6606493
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
Transportation Radioactive Materials
Novel Radionuclides
Prismap D9.1-First public report from the PRISMAP work package 9 (WP9, transport and logistics)
info:eu-repo/semantics/report
oai:zenodo.org:7154340
2022-10-07T14:17:18Z
user-medical_radionuclides_eu
user-eu
Maija Radzina
Edgars Mamis
Laura Saule
Elina Pajuste
Marika Kalnina
Thomas Cocolios
Zeynep Talip
Thierry Stora
2022-09-30
<p>This document is a summary of responses received from the public known European industrial manufacturing and research institution and clinical facility representatives. The responses were given to the PRISMAP Consortium questionnaire disseminated in January-August 2022, approaching radionuclides and radiopharmaceutical manufacturers, research institutions and clinical end users in nuclear medicine, with the aim to identify potential stakeholders in the industrial and clinical communities interested by a coordinated approach in Europe such as PRISMAP.</p>
<p>The summary from PRISMAP questionnaire stratifies the feedback from 114 respondents: radionuclide and radiopharmaceutical producers, research facilities and preclinical/clinical end users. In addition, it gives an insight into the location and capabilities of the main isotope-producing cyclotron facilities, many of which are known from the IAEA cyclotron database [2]). The questionnaire was offered with an opportunity to make new research and international collaboration partners, where all parties could benefit from harmonised supply and legislation procedures, expanding network and distribution routes, and subsequently gain visibility within the PRISMAP User Forum map at www.prismap.eu. The questionnaire was focused on the radionuclide use in medicine with emphasis on future needs for specific radionuclides and possible research developments with awareness of legislation, logistics and involved personnel education challenges and future perspectives.</p>
https://doi.org/10.5281/zenodo.7154340
oai:zenodo.org:7154340
eng
Zenodo
https://zenodo.org/communities/medical_radionuclides_eu
https://zenodo.org/communities/eu
https://doi.org/10.5281/zenodo.7154339
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
PRISMAP; questionnaire; nuclear medicine; radiopharmaceutical manufacturers; research institutions; clinical end users;
Deliverable 5.1 - Questionnaire on industrial and clinical key players and needs
info:eu-repo/semantics/report
oai:zenodo.org:7913190
2023-05-15T12:26:27Z
user-medical_radionuclides_eu
user-eu
Manzolaro Mattia
Corradetti Stefano
Pupillo Gaia
Popescu Lucia
2023-05-09
<p>This deliverable is the Proceedings book of the PRISMAP workshop 1 “PRISMAP workshop on emerging infrastructures and technical developments”.</p>
<p>The Workshop on Emerging Infrastructures and Technical Developments was organised at Legnaro National Laboratories on 21-24 November 2022. The Workshop gave a general update on international facilities producing radionuclides, identified the most promising radionuclides on which production R&D shall focus in the near future, and presented the latest technical developments on targets, ion sources and mass separation techniques. This is one of the two events organised within the WP8: Involvement of Emerging Infrastructures.</p>
<p>The workshop was organised in a hybrid format, registering 76 participants, out of which 39 in person and 37 remotely. The first day of the workshop included 15 talks dedicated to infrastructures and radionuclides programmes. The second day was dedicated to more technical topics, including 9 technical talks covering the major activities performed within WP10: on targets, ion sources and isotopes purification. The on-site participants could join a visit to SPES facilities, enjoying a unique opportunity to enter all sections of this ISOL facility which is getting ready to start the beam commissioning. Furthermore, a poster session has been organised, where 9 posters have been presented. Proceedings contributions from some of the posters are included in this Book of Proceedings.</p>
https://doi.org/10.5281/zenodo.7913190
oai:zenodo.org:7913190
eng
Zenodo
https://zenodo.org/communities/medical_radionuclides_eu
https://zenodo.org/communities/eu
https://doi.org/10.5281/zenodo.7913189
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
high purity isotopes
high purity radionuclides
radiopharmaceuticals
mass separation
nuclear reactors
high power cyclotrons
isotope mass separation facilities
biomedical research facilities
PRISMAP Deliverable D8.1 - Proceedings book workshop 1
info:eu-repo/semantics/report