Letter to the Editor
Radiochemical purity testing of 99mTc-labelled radiopharmaceuticals: Nothing, except everything, is enough
Pruebas de pureza radioquímica de radiofármacos marcados con 99mTc: nada, excepto todo, es suficiente
Jesús Luis Gómez Perales
, María Teresa Gutiérrez Amares
Corresponding author
Servicio de Medicina Nuclear, Hospital Universitario “Puerta del Mar” de Cádiz, Servicio Andaluz de Salud, Spain. Facultad de Medicina, Universidad de Cádiz, Spain
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"apellidos" => "Mora Salvadó" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S2253654X17303165" "doi" => "10.1016/j.remn.2018.01.006" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2253654X17303165?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2253808918300089?idApp=UINPBA00004N" "url" => "/22538089/0000003700000006/v3_201812190625/S2253808918300089/v3_201812190625/en/main.assets" ] "itemAnterior" => array:19 [ "pii" => "S2253808918300818" "issn" => "22538089" "doi" => "10.1016/j.remnie.2018.10.009" "estado" => "S300" "fechaPublicacion" => "2018-11-01" "aid" => "1018" "copyright" => "Sociedad Española de Medicina Nuclear e Imagen Molecular" "documento" => "article" "crossmark" => 1 "subdocumento" => "fla" "cita" => "Rev Esp Med Nucl Imagen Mol. 2018;37:373-9" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 5 "formatos" => array:2 [ "HTML" => 1 "PDF" => 4 ] ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Special collaboration</span>" "titulo" => "Next generation of radiotracers for sentinel lymph node biopsy: What is still necessary to establish new imaging paradigms?" 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Facultad de Medicina, Universidad de Cádiz, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Pruebas de pureza radioquímica de radiofármacos marcados con <span class="elsevierStyleSup">99m</span>Tc: nada, excepto todo, es suficiente" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1147 "Ancho" => 1450 "Tamanyo" => 110761 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Probability of detecting all and each one of the failed products versus the percentage of tested preparations for one, two and three failed products.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Extemporaneous technetium radiopharmaceuticals constitute a very important part of radiopharmaceuticals used in nuclear medicine. Its preparation entails a sequence of reactions and involves the formation of new chemical species. Consequently, there are several factors that can affect their radiochemical purity such as low specific activity of the generator eluates or chemical changes due to inadequate storage conditions, residues of cleaning agents on the septum of the vial or bad praxis during its preparation.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Radiochemical purity (RCP) is defined as the fraction of the total radioactivity in the desired chemical form of a radiopharmaceutical. Radiochemical impurities have different biodistribution that the radiopharmaceutical, being different chemical species. Therefore, unacceptable amounts of radiochemical impurities in a radiopharmaceutical preparation would result in altered biodistribution of the preparation and poor image quality. Accordingly, it can have a significant clinical impact on safety, scan interpretation and diagnostic accuracy of the imaging procedure. In their most extreme manifestations, unanticipated imaging results may even compromise the accuracy and utility of nuclear medicine studies,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> and eventually it could even lead to a misdiagnosis. For these reasons the relevant radiochemical impurities are listed with their limits in the individual monographs and the requirement of the radiochemical purity must be fulfilled throughout the period of validity of every radiopharmaceutical.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Therefore, RCP is a very important quality parameter for technetium radiopharmaceuticals. It has been reported that routine RCP testing programmes have been beneficial and several guidelines state that periodic RCP testing should be carried out in every radiopharmacy.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">On the other hand, RCP testing does not require special equipment, because in a hospital environment thin-layer and paper chromatography are mostly used to determine RCP. It has been reported<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> that the direct costs of RCP testing were less than the direct costs of preparing replacement doses of failed products, and that inclusion of indirect costs further strengthened the cost effectiveness of RCP testing.</p><p id="par0025" class="elsevierStylePara elsevierViewall">In an editorial by Ballinger and Blower,<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> they refute that RCP testing of <span class="elsevierStyleSup">99m</span>Tc-labelled radiopharmaceuticals is a complete waste of time, statement also made by some scientists. In that editorial they also accepted the premise that testing every product is not essential and raised the question “how much is enough?” that is “what frequency should we set as a minimum standard?” They came to the conclusion that the exact frequency of periodic testing must be determined locally and supported by a risk assessment. They also added that there are several factors that could be considered in selecting which products must be sample, such as the effects of Monday elution and preparation by newly trained or retrained staff.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Nevertheless, in light of all the above arguments and based on probabilistic grounds, we strongly advocate testing each and every extemporaneous preparation of technetium radiopharmaceuticals. Let us try to explain it below.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The probability of detecting all and each one of the failed products can be calculated through combinatorial methods by the following formula:<elsevierMultimedia ident="eq0005"></elsevierMultimedia>where <span class="elsevierStyleItalic">n</span> is the total number of radiopharmaceutical preparations, <span class="elsevierStyleItalic">f</span> is the number of failed preparations, <span class="elsevierStyleItalic">d</span> is the number of failed preparations we want to detect and <span class="elsevierStyleItalic">t</span> is the number of performed RCP tests.</p><p id="par0040" class="elsevierStylePara elsevierViewall">According to the published data, the true frequency of RCP failures varies between 0.24% and 2.6% of all the tested preparations.<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">3–5</span></a> To simplify calculations let's suppose a frequency of RCP failures of 1%. That means that one out of 100 preparations does not meet the minimum required RCP (failed product). If we test the RCP of 10 of those 100 preparations, the probability of detecting the failed product is 10%. If we test the RCP of 20 of them, the probability of detecting the failed product is 20%. And so systematically, until if we test 100% of preparations, the probability of detecting the failed product is 100%.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Now let's suppose a frequency of RCP failures of 2%. That means that two out of 100 preparations are failed products. If we test the RCP of 10 of them, the probability of detecting the failed products is 0.9%. If we test the RCP of 20 of them, the probability of detecting the failed products is 3.8%. If we test the RCP of 50 of them, the probability of detecting the failed products is 24.8%. And so on, until if we test 100% of preparations, the probability of detecting the failed products is 100%.</p><p id="par0050" class="elsevierStylePara elsevierViewall">The odds are even lower if the frequency of RCP failures is 3% (see <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0055" class="elsevierStylePara elsevierViewall">Extrapolation of the above data leads to two clear conclusions. Firstly, for the same number of controls performed on the same number of preparations, the probability of detecting all and each one of the failed products decreases as their number increases. And secondly, whatever the number of preparations, we will only have absolute certainty of detecting all and each one of the failed products if each and every one of the preparations (100%) are tested. This can be seen graphically in <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">In conclusion, in light of the discussion above and emphasizing the fact that RCP testing techniques of technetium radiopharmaceuticals are very inexpensive, very simple and very quick to perform, it is hard to argue against testing every product as carried out for all other drugs. RCP testing of extemporaneous radiopharmaceuticals has an important role to play but only if they are able to detect any failed product. Therefore, we stress the need for routine quality control of each and every technetium radiopharmaceutical. In our opinion, RCP testing should be considered as part of the routine work in every radiopharmacy.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Competing interests</span><p id="par0065" class="elsevierStylePara elsevierViewall">The authors declare that they have no competing interests.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Funding</span><p id="par0070" class="elsevierStylePara elsevierViewall">Funding information is not applicable because no funding was received.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Competing interests" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Funding" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0020">Please cite this article as: Gómez-de la Fuente FJ, Martínez-Rodríguez I, de Arcocha-Torres M, Quirce R, Jiménez-Bonilla J, Martínez-Amador N, et al. Aportación de la PET/TC con <span class="elsevierStyleSup">11</span>C-colina en la recidiva bioquímica del cáncer de próstata con PSA sérico inferior a 1<span class="elsevierStyleHsp" style=""></span>ng/ml. Rev Esp Med Nucl Imagen Mol. 2018;37:380–381.</p>" ] ] "multimedia" => array:3 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1147 "Ancho" => 1450 "Tamanyo" => 110761 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Probability of detecting all and each one of the failed products versus the percentage of tested preparations for one, two and three failed products.</p>" ] ] 1 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:1 [ "tablaImagen" => array:1 [ 0 => array:4 [ "imagenFichero" => "fx1.jpeg" "imagenAlto" => 171 "imagenAncho" => 1400 "imagenTamanyo" => 61817 ] ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Probability of detecting all and each one of the failed products versus the percentage of tested preparations for one, two and three failed products.</p>" ] ] 2 => array:5 [ "identificador" => "eq0005" "tipo" => "MULTIMEDIAFORMULA" "mostrarFloat" => false "mostrarDisplay" => true "Formula" => array:5 [ "Matematica" => "p(d)=fdn−ft−dnt" "Fichero" => "STRIPIN_si1.jpeg" "Tamanyo" => 2975 "Alto" => 83 "Ancho" => 155 ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Altered biodistribution of radiopharmaceuticals: role of radiochemical/pharmaceutical purity physiological, and pharmacologic factors" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "S. 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