Prostate cancer is considered the most common type of neoplasm in the male population in Italy and in Western countries, with an ever-increasing incidence due to the increased presence of risk factors. Fortunately, laboratory techniques and diagnostic tests are also available and these allow early diagnosis of the disease, and thus a prompt and more effective possibility of treatment. This paper has been produced thanks to an analysis of the medical-nuclear and radiopharmaceutical activity of the Istituto Oncologico Veneto (IOV) of Castelfranco Veneto. The institute represents one of the few health centres in the Veneto Region where it is possible to carry out the diagnostic investigation which is the subject of the following paper for the study of prostate cancer. The following paper will discuss the use of the radiopharmaceutical 68Ga-PSMA-11 associated with PET/CT imaging for the study of prostate carcinoma, in particular in the case of biochemical recurrence before or after radical prostatectomy and in the event of tumour recurrence following radiotherapy. This paper analyzes the production process of the radiopharmaceutical consisting of the radioisotope Gallium-68, obtained by the elution of a Germanium chloride (68Ge) - Gallium chloride (68Ga) generator in a radiopharmacy with dedicated rooms: once the radioisotope is produced, it is synthesised with PSMA (Prostate Specific Membrane Antigen), a peptide consisting of a glycoprotein present on prostate cells. This allows the radiopharmaceutical to be specific and selective in localising in the disease sites, characterised by a high presence of these cells. Next, the radiopharmaceutical quality control processes are described: these are divided into pre-release and post-release controls, which include tests for pH measurement, visual inspection, radionuclidic purity, chemical and radiochemical purity, as well as sterility and residual solvent control. The results of these controls are collected within the radiopharmaceutical batch record, which must be structured and stored according to Good Radiopharmaceutical Preparation Standards. Thanks to a careful observation of the work processes within the Complex Operative Unit of Nuclear Medicine of the IOV, it was possible to describe in detail the procedure to which each patient, who has to undergo this type of investigation, is subjected, starting from the interview with the nuclear doctor before the intravenous injection of the radiopharmaceutical, to the its administration, up to the acquisition of the images with the PET/CT tomograph in the U.O.C. Also noteworthy is the presentation of the analysis of the images obtained from radiopharmaceutical administration, with an explanation of the main physiological accumulation sites (prostate, duodenum, colon, parotid glands, submandibular salivary glands, spleen, lacrimal glands and liver) and the most frequent pitfalls that can mimic a pathological uptake site, inducing a misdiagnosis. There is also a focus on the figure of the Medical Radiology Technician in the field of nuclear medicine, in order to highlight the importance of this figure within the process of performing the investigation, both from a purely technical point of view and in the management of the patient before, during and after the examination. Finally, the importance of this innovative, minimally invasive diagnostic technique was outlined, the demand for which is constantly growing, such as the diagnoses of prostate neoplasia. In the next few years, therefore, it is expected that special kits for the synthesis of 68Ga-PSMA-11 will be marketed, in order to increase the number of centres that would give patients the opportunity to perform this diagnostic test, as this radiopharmaceutical could also be produced in nuclear medicine that does not have a radiopharmacy with synthesis modules.
Il carcinoma prostatico è considerato il tipo di neoplasia più diffusa nella popolazione maschile in Italia e nei Paesi Occidentali, con un’incidenza in continuo aumento a causa della maggiore presenza di fattori di rischio. Fortunatamente sono anche disponibili tecniche di laboratorio ed esami diagnostici che permettono una diagnosi precoce di malattia, quindi una possibilità di trattamento repentina e più efficace. Questo elaborato è stato prodotto grazie ad un’analisi dell’attività medico-nucleare e radiofarmaceutica dell’Istituto Oncologico Veneto (IOV) nella sua sede di Castelfranco Veneto, in quanto rappresenta uno dei pochi centri sanitari nella Regione Veneto in cui è possibile effettuare l’indagine diagnostica oggetto del seguente elaborato per lo studio della neoplasia prostatica. Di seguito verrà trattato l’utilizzo del radiofarmaco 68Ga-PSMA-11 associato alla metodica medico-nucleare PET/CT per lo studio del carcinoma prostatico, in particolare nel caso di ripresa biochimica prima o dopo prostatectomia radicale e nell’eventuale ripresentazione tumorale in seguito a radioterapia. In questo elaborato si è analizzato il processo di produzione del radiofarmaco formato dal radioisotopo Gallio-68, ottenuto grazie ad un generatore Germanio cloruro (68Ge) – Gallio cloruro (68Ga) all’interno di una radiofarmacia con locali dedicati: una volta prodotto il radioisotopo, questo viene sintetizzato con il PSMA (Prostate Specific Membrane Antigen), ovvero un peptide formato da una glicoproteina presente sulle cellule prostatiche. Questo permette al radiofarmaco di essere specifico e selettivo nel localizzarsi nei punti di malattia, caratterizzati da un’alta presenza di queste cellule. Successivamente si è proceduto a descrivere i processi di controllo di qualità del radiofarmaco, suddivisi in controlli pre-rilascio e post-rilascio che comprendono test per la misurazione del pH, il controllo visivo, la purezza radionuclidica, la purezza chimica e radiochimica, nonché la sterilità e il controllo di solventi residui. I risultati di tali controlli vengono raccolti all’interno del batch record del radiofarmaco che deve essere strutturato e conservato secondo le Norme di Buona Preparazione dei Radiofarmaci. Grazie ad un’attenta osservazione dei processi lavorativi all’interno dell’Unità Operativa Complessa di Medicina Nucleare dello IOV, è stato possibile descrivere nel dettaglio l’iter al quale ogni paziente che deve eseguire questo tipo di indagine viene sottoposto, partendo dal colloquio con il medico nucleare prima dell’iniezione endovenosa del radiofarmaco, alla somministrazione dello stesso, fino all’acquisizione delle immagini tramite il tomografo PET/CT presente nell’U.O.C. Degna di nota è anche la presentazione dell’analisi delle immagini ottenute dalla somministrazione del radiofarmaco, con un’esposizione dei principali siti di accumulo fisiologici (prostata, duodeno, colon, parotidi, ghiandole salivari sottomandibolari, milza, ghiandole lacrimali e fegato) e dei pitfalls più frequenti che possono mimare un sito di captazione patologica, inducendo una diagnosi errata. Viene inoltre eseguito un focus sulla figura del Tecnico Sanitario di Radiologia Medica nel campo della medicina nucleare, in modo da far emergere l’importanza di questa figura all’interno del processo di esecuzione dell’indagine, sia dal punto di vista puramente tecnico, sia nella gestione del paziente prima, durante e dopo l’esame. Infine, è stata delineata l’importanza di questa tecnica diagnostica innovativa minimamente invasiva per il paziente, la cui domanda è in continua crescita, così come le diagnosi di neoplasia prostatica. Nei prossimi anni si prevede quindi l’immissione in commercio di KIT appositi per la sintesi del 68Ga-PSMA-11, grazie ai quali la quantità di centri che darebbero l’opportunità ai pazienti di eseguire questo esame diagnostico aumenterebbe.
68Ga-PSMA-11 PER LO STUDIO DELLE NEOPLASIE PROSTATICHE: DALLA PRODUZIONE DEL RADIOFARMACO ALL’ESECUZIONE DELL’ESAME CON DIAGNOSTICA PET/CT
STANGHERLIN, ALESSIA
2022/2023
Abstract
Prostate cancer is considered the most common type of neoplasm in the male population in Italy and in Western countries, with an ever-increasing incidence due to the increased presence of risk factors. Fortunately, laboratory techniques and diagnostic tests are also available and these allow early diagnosis of the disease, and thus a prompt and more effective possibility of treatment. This paper has been produced thanks to an analysis of the medical-nuclear and radiopharmaceutical activity of the Istituto Oncologico Veneto (IOV) of Castelfranco Veneto. The institute represents one of the few health centres in the Veneto Region where it is possible to carry out the diagnostic investigation which is the subject of the following paper for the study of prostate cancer. The following paper will discuss the use of the radiopharmaceutical 68Ga-PSMA-11 associated with PET/CT imaging for the study of prostate carcinoma, in particular in the case of biochemical recurrence before or after radical prostatectomy and in the event of tumour recurrence following radiotherapy. This paper analyzes the production process of the radiopharmaceutical consisting of the radioisotope Gallium-68, obtained by the elution of a Germanium chloride (68Ge) - Gallium chloride (68Ga) generator in a radiopharmacy with dedicated rooms: once the radioisotope is produced, it is synthesised with PSMA (Prostate Specific Membrane Antigen), a peptide consisting of a glycoprotein present on prostate cells. This allows the radiopharmaceutical to be specific and selective in localising in the disease sites, characterised by a high presence of these cells. Next, the radiopharmaceutical quality control processes are described: these are divided into pre-release and post-release controls, which include tests for pH measurement, visual inspection, radionuclidic purity, chemical and radiochemical purity, as well as sterility and residual solvent control. The results of these controls are collected within the radiopharmaceutical batch record, which must be structured and stored according to Good Radiopharmaceutical Preparation Standards. Thanks to a careful observation of the work processes within the Complex Operative Unit of Nuclear Medicine of the IOV, it was possible to describe in detail the procedure to which each patient, who has to undergo this type of investigation, is subjected, starting from the interview with the nuclear doctor before the intravenous injection of the radiopharmaceutical, to the its administration, up to the acquisition of the images with the PET/CT tomograph in the U.O.C. Also noteworthy is the presentation of the analysis of the images obtained from radiopharmaceutical administration, with an explanation of the main physiological accumulation sites (prostate, duodenum, colon, parotid glands, submandibular salivary glands, spleen, lacrimal glands and liver) and the most frequent pitfalls that can mimic a pathological uptake site, inducing a misdiagnosis. There is also a focus on the figure of the Medical Radiology Technician in the field of nuclear medicine, in order to highlight the importance of this figure within the process of performing the investigation, both from a purely technical point of view and in the management of the patient before, during and after the examination. Finally, the importance of this innovative, minimally invasive diagnostic technique was outlined, the demand for which is constantly growing, such as the diagnoses of prostate neoplasia. In the next few years, therefore, it is expected that special kits for the synthesis of 68Ga-PSMA-11 will be marketed, in order to increase the number of centres that would give patients the opportunity to perform this diagnostic test, as this radiopharmaceutical could also be produced in nuclear medicine that does not have a radiopharmacy with synthesis modules.File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/56971