asound implementation U LT R A S OU N D 1 5 Supporting the next generation of doctors Fujifilm SonoSite maintains its strong focus on supporting medical train- ing and education, and recently supplied instruments for a series of ultrasound workshops at the Doctors Academy International Medical Summer School. Doctors Academy is one of the world’s largest providers of inde- pendent medical education. Ultrasound workshops prove very popular among delegates, since the opportunity to gain hands-on expe- rience in this area is necessary to fully understand the basics of the technique. Professor Stuart Enoch, a surgeon by training and now the CEO of Doctors Academy, explained: ‘We focus on responding to the aca- demic needs of medical students and junior doctors by delivering specialised knowledge advancement and skills courses that are not avail- able via traditional routes. ‘Medical students and junior doc- tors are seldom given the chance to perform and interpret ultrasound scans during their education or training. The workshop covers the fundamental principles of ultra- sound, including the interpretation of core organs and choosing the most appropriate probes to use in different situations. Our tutors focus on a series of real-life scenarios, and discuss whether MRI, CT or ultrasound is the most appropri- ate investigative technique. This is followed by a demonstration and a practical session, enabling del- egates to perform ultrasound scans for themselves, which explains the popularity of the workshop.’ Professor Giancarlo Bizzarri is the Head of the Interventional and Diagnostic Radiology Department at Regina Apostolorum Hospital – Albano Laziale (Rome, Italy) easy matching and precise real-time tracking. These new 2-D mapping techniques may provide tremendous support in the accurate diagnosis and proper planning of surgery and interventional procedures such as core biopsies and FNA procedures.’ ‘Because BodyMap 2-D naviga- tion, 3-D Fusion Imaging, and Virtual Biopsy techniques can increase the diagnostic confidence of the opera- tor, in different parts of the body, there are countless possible applica- tions. ‘Simplified and automatic fusion technologies and customised proto- cols will reduce the learning curve for the operator, and will help to make all these techniques more widespread. New developments and future impact ‘The main efforts in medical imaging are now directed towards preven- tion, diagnosis, selection of optimal (personalised) therapy (local/sys- temic), guidance of local treatments, assessment of therapy results (local/ systemic) and disease follow-up. All these objectives require information to be not only archived and com- municated, but also co-registered and processed by fusion and virtual reality software algorithms. ‘In the near future, these new technologies will be integrated into all imaging and diagnostic modali- ties, PACS, Oncology Information Systems, and HIS, going beyond the simple radiological environment and spreading throughout all diag- nostic and therapeutic fields.’ Real-time image fusion techniques allow ultrasound to be spatially co-registered with multiple volumetric image diagnostic modalities, such as those from MRI, CT, PET, and even with 2-D Dicom images. www.healthcare-in-europe.com Bibliography 1. Laurent S, Elst LV, Muller RN. Comparative study of the physicochemical properties of six clinical low molecular weight gadolinium contrast agents. Contrast Media Mol Imaging. 2006;1(3):128-37 2. Lohrke J, Frisk AL, Frenzel T, et al. Histology and gadolinium distribution in the rodent brain after the administration of cumulative high doses of linear and macrocyclic gadolinium-based contrast agents. Invest Radiol. 2017;52(6):324-33 3. Bussi S, Tedoldi F, Maisano F, et al. Differences in gadolinium retention after repeated injections of macrocyclic contrast agents to rats. J Magn Res Imaging. 2017. DOI:10.1002/jmri.25822 4. Maravilla K, Smith MP, Vymazal J, et al. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). AJNR Am J Neuroradiol. 2015;36(1):14-23 5. Gutierrez JE, Rosenberg M, Seemann J, et al. Safety and Efficacy of Gadobutrol for Contrast-enhanced Magnetic Resonance Imaging of the Central Nervous System: Results from a Multicenter, Double-blind, Randomized, Comparator Study. Magn Reson Insights. 2015;8:1-10 6. Yoshikawa K, Davies A. Safety of ProHance in special populations Eur Radiol 1997;7 Suppl 5:246-50 7. Runge VM, Parker JR. Worldwide clinical safety assessment of gadoteridol injection: an update. Eur Radiol. 1997;7 Suppl 5:243-45 8. Morgan DE, Spann JS, Lockhart ME, et al. Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients. Radiology. 2011;259(1):109-16 9. Murata N, Gonzalez-Cuyar LF, Murata K, et al. Macrocyclic and Other Non-Group 1 Gadolinium Contrast Agents Deposit Low Levels of Gadolinium in Brain and Bone Tissue: Preliminary Results From 9 Patients With Normal Renal Function. Invest Radiol. 2016;51(7):447-53 10. McDonald RJ, McDonald JS, Dai D, Schroeder D, Jentoft ME, Murray DL, Kadirvel R, Eckel LJ, Kallmes DF. Radiology. 2017 Jun 19:161594. doi: 10.1148/radiol.2017161594. [Epub ahead of print].11. Questions and answers on the review of gadolinium-containing contrast agents. Doc. ref. EMEA/727399/2009 rev. EMEA/H/A-31/1097, July 1 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/gadolinium_31/WC500015635.pdf 12. ACR Manual on Contrast Media – Version 10.2, 2016. Nephrogenic systemic fibrosis. Available at: https://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Resources/Contrast-Manual/2016_Contrast_Media.pdf/#page=89 13. Bellin MF, Van Der Molen AJ. Extracellular gadolinium-based contrast media: an overview. Eur J Radiol. 2008;66(2):160-7 14. Bracco data on file 15. Sardanelli F, Giuseppetti GM, Panizza P, et al. Sensitivity of MRI Versus Mammography for Detecting Foci of Multifocal, Multicentric Breast Cancer in Fatty and Dense Breasts Using the Whole-Breast Pathologic Examination as a Gold Standard. AJR Am J Roentgenol. 2004;183(4):1149-57 16. Deurloo EE, Peterse JL, Rutgers E, et al. Additional breast lesions in patients eligible for breast-conserving therapy by MRI: Impact on preoperative management and potential benefit of computerised analysis. Eur J Cancer. 2005;41(10):1393-401 17. Le Y, Kipfer HD, Nickel DM, et al. Initial Experience of Applying TWIST-Dixon With Flexible View Sharing in Breast DCE- MRI, Clin Breast Cancer, Vol.16, N.3, 202-6 2015 18. Loo CE, Teertstra HJ, Rodenhuis S, et al. Dynamic Contrast-Enhanced MRI for Prediction of Breast Cancer Response to Neoadjuvant Chemotherapy: Initial Results, AJR:191, November 2008 19. Ishibashi M, Fujii S, Kawamoto K, et al. Capsule of parotid gland tumor: evaluation by 3.0 T magnetic resonance imaging using surface coils. Acta Radiol. 2010;51(10):1103-10 20. Akai T, Taniguchi D, Oda R, et al. Prediction of radiographic progression in synovitis-positive joints on maximum intensity projection of magnetic resonance imaging in rheumatoid arthritis. Clin Rheumatol. 2016;35(4):873-8 21. Liu PT, Chivers FS, Roberts CC, et al. Imaging of Osteoid Osteoma with Dynamic Gadolinium enhanced MR Imaging. Radiology 2003;227:691-700 SUMMARY OF PRODUCT CHARACTERISTICS For prescribing information please refer to the approved SPC in your country. ProHance, 0.5 M solution for injection Composition 1 ml of solution for injection contains: gadoteridol 279.3 mg/ml (0.5 M) Excipients Calteridol Calcium, Tromethamine USP, Hydrochloric Acid Ph Eur, Sodium Hydroxide Ph Eur, Water for Injections Ph Eur Therapeutic indications Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier. ProHance can also be used for whole body MRI including the head, neck, liver, breast, muscoloskeletal system and soft tissue pathologies. Contra-indications Hypersensitivity to the active substance, or to any of the excipients or to other gadolinium-based contrast. ProHance is contraindicated in children under 66 months of age. Special warnings and special precaution for use Patients with a history of allergy, drug reactions, or other hypersensitivity-like disorders should be closely observed during the procedure and the contrast medium administration, as well as for the time the physician deems useful given the patient condition. As with other gadolinium chelates, there have been reports of anaphylactic/anaphylactoid/ hypersensitivity reactions with gadoteridol. These reactions manifested with various degrees of severity, including anaphylactic shock or death. They involved one or more body systems, mostly respiratory, cardiovascular and/or mucocutaneous systems. Anaphylac-tic shock has been very rarely been reported with the use of gadoteridol. Appropriate drugs and instruments for emergency measures must be readily available. In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased. Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available. Transitory changes in serum iron (within normal range in the majority of cases) have been observed in some patients after administration of ProHance and these changes were shown not to be clinically significant. Since Gadoteridol is renally cleared from the body, caution should be exercised in patients with severely impaired renal function. Undesirable Effects The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when ProHance is used for contrast enhancement. The following adverse reactions have been reported with ProHance. Adverse reactions from clinical trials have been included with an indication of the frequency. Adverse reactions from spontaneous reporting are included with the frequency “not known”. There were no adverse reactions with an incidence greater than 2%. Common (≥ 1/100, < 1/10): Gastrointestinal disorders; Nausea Uncommon (≥ 1/1,000, < 1/100): Nervous system disorders; headache, paraesthesia, dizziness, taste disturbance. Eye disorders; increased lacrimation. Vascular disorders; flushing, hypotension. Gastrointestinal disorders; dry mouth, vomiting. Skin and subcutaneous tissue disorders; pruritus, rash, urticaria. General disorders and administration site conditions; injection site pain, asthenia. Investigations; heart rate increased. Rare (1/10,000, < 1/1,000): Immune system disorders; Anaphylactic/anaphylactoid reactions. Psychiatric disorders; anxiety. Nervous system disorders; mental impairment, abnormal coordination, convulsion. Ear and labyrinth disorders; tinnitus. Cardiac disorders; nodal arrhythmia. Respiratory, thoracic and mediastinal disorders; laryngospasm, dyspnoea, rhinitis, cough, apnea, wheezing. Gastrointestinal disorders; abdominal pain, tongue oedema, oral pruritus, gingivitis, loose stools. Skin and subcutaneous tissue disorders; oedema face. Musculoskeletal and connective tissue disorders; musculoskeletal stiffness. General disorders and administration site conditions; chest pain, pyrexia. Not known (cannot be estimated from the available clinical trial data): Nervous system disorders; loss of consciousness, coma, vasovagal reactions. Cardiac disorders; cardiac arrest. Renal and urinary system; acute renal failure; Respiratory, thoracic and mediastinal disorders; respiratory arrest, pulmonary oedema. Additional Safety Information Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with ProHance, most of which were in patients co-administered other gadolinium-containing contrast agents (see below). Impaired renal function Prior to administration of ProHance, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73 m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with ProHance, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. Haemodialysis shortly after ProHance administration may be useful at removing ProHance from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis. Infants from 6 months to 1 year of age Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days. Use of ProHance is not recommended in children less than 6 months of age. Use for whole body MRI is not recommended in children less than 18 years of age. Elderly (aged 65 years and above) As the renal clearance of gadoteridol may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction. Please note The peel-off tracking label on the vials should be stuck onto the patient records to enable accurate recording of the gadolinium contrast agent used (EU). The dose used should also be recorded (EU). Consult the locally approved package insert. The Marketing Authorisation Holder, the Marketing Authorisation number and the date of approval may be different in different countries. For current prescribing information refer to the package insert and/or contact your local BRACCO organisation. Date of revision of this text September 2016.Proven efficacy4,5,15-21Large worldwide experience with over 25 million doses administered14Low risk of nephrogenic systemic fibrosis (NSF)11,12Established safety profile4-10Macrocyclic GBCA with very high in vivo stability1-3Low viscosity and osmolality13