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EANM Procedure Guideline for the Treatment of Liver Cancer and Liver Metastases with Intra-Arterial Radioactive Compounds

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EANM Procedure Guideline for the Treatment of Liver Cancer and Liver Metastases with Intra-Arterial Radioactive Compounds Eur J Nucl Med Mol Imaging DOI 10.1007/s00259-011-1812-2 GUIDELINES EANM procedure guideline for the treatment of liver cancer and liver metastases with intra-arterial radioactive compounds Francesco Giammarile & Lisa Bodei & Carlo Chiesa & Glenn Flux & Flavio Forrer & Françoise Kraeber-Bodere & Boudewijn Brans & Bieke Lambert & Mark Konijnenberg & Françoise Borson-Chazot & Jan Tennvall & Markus Luster & the Therapy, Oncology and Dosimetry Committees # EANM 2011 Abstract Primary liver cancers (i.e. hepatocellular carci- surgery (i.e. resection or liver transplantation), but only 10– noma or cholangiocarcinoma) are worldwide some of the 20% of patients are candidates for this. In other patients, a most frequent cancers, with rapidly fatal liver failure in a variety of palliative treatments can be given, such as large majority of patients. Curative therapy consists of chemoembolization, radiofrequency ablation or recently F. Giammarile (*) B. Lambert Hospices Civils de Lyon, Service de Médecine Nucléaire, Department of Nuclear Medicine, Centre Hospitalier Lyon-Sud and Université Claude Bernard Lyon Ghent University Hospital, 1, EA 3738, Ghent, Belgium Lyon, France e-mail: [email protected] L. Bodei M. Konijnenberg Division of Nuclear Medicine, European Institute of Oncology, Nuclear Medicine Department, Milan, Italy Erasmus MC, Rotterdam, The Netherlands C. Chiesa Nuclear Medicine, Foundation IRCCS National Tumour Institute, Milan, Italy F. Borson-Chazot G. Flux Hospices Civils de Lyon, Fédération d’endocrinologie, Royal Marsden Hospital & Institute of Cancer Research, Université Lyon 1, INSERM U664, Sutton, Surrey, UK Lyon, France F. Forrer Department of Nuclear Medicine, University Hospital Basel, Basel, Switzerland J. Tennvall Department of Oncology, Lund University, F. Kraeber-Bodere Skane University Hospital, University hospital, Rene Gauducheau cancer center, Lund, Sweden CRCNA unit 892, Nantes, France B. Brans M. Luster Department of Nuclear Medicine, Department of Nuclear Medicine, University Medical Center Maastricht, University of Ulm, Maastricht, The Netherlands Ulm, Germany Eur J Nucl Med Mol Imaging introduced tyrosine kinase inhibitors, e.g. sorafenib. Colo- 131I-Lipiodol is a consolidated treatment option and the rectal cancer is the second most lethal cancer in Europe and previous European Association of Nuclear Medicine liver metastases are prevalent either at diagnosis or in (EANM) guidelines have been revised for its use. The follow-up. These patients are usually treated by a sequence newer 90Y-microsphere therapy is rapidly expanding of surgery, chemotherapy and antibody therapy [Okuda et throughout the nuclear medicine community. To date, al. (Cancer 56:918–928, 1985); Schafer and Sorrell (Lancet published data on microspheres, particularly on dosimetry 353:1253–1257, 1999); Leong et al. (Arnold, London, features and the characterization of the objective response, 1999)]. Radioembolization is an innovative therapeutic are still preliminary. Therefore, the aim of this part of the approach defined as the injection of micron-sized embolic document is to set up a first basic procedure to guide particles loaded with a radioisotope by use of percutaneous nuclear medicine physicians in treatment with radiolabelled intra-arterial techniques. Advantages of the use of these microspheres. intra-arterial radioactive compounds are the ability to deliver high doses of radiation to small target volumes, the relatively low toxicity profile, the possibility to treat the Background information and definitions whole liver including microscopic disease and the feasibil- ity of combination with other therapy modalities. Disad- Definitions vantages are mainly due to radioprotection constraints mainly for 131I-labelled agents, logistics and the possibility 1. Radionuclides of inadvertent delivery or shunting [Novell et al. (Br J Surg – 131I is a beta-emitting radionuclide with a physical 78:901–906, 1991)]. The Therapy, Oncology and Dosime- half-life of 8.04 days. The maximum and mean try Committees have worked together in order to revise the beta particle energies are 0.61 and 0.192 MeV, European Association of Nuclear Medicine (EANM) guide- respectively. The maximum and mean ranges in lines on the use of the radiopharmaceutical 131I-Lipiodol soft tissue are 2.4 and 0.9 mm, respectively. 131I (Lipiocis®, IBA, Brussels, Belgium) and include the newer emits a principal gamma photon of 364 keV (81% medical devices with 90Y-microspheres. 90Y is either bound abundance). to resin (SIR-Spheres®, Sirtex Medical, Lane Cove, – 90Y is a beta-emitting radionuclide with a physical Australia) or embedded in a glass matrix (TheraSphere®, half-life of 2.67 days (64.2 h), without emission of MDS Nordion, Kanata, ON, Canada). Since 90Y-micro- gamma photons, but with the emission of secondary spheres are not metabolized, they are not registered as “bremsstrahlung” Xphotons.1 The maximum and unsealed sources. However, the microspheres are delivered mean beta particle energies are 2.26 and 0.94 MeV, in aqueous solution: radioactive contamination is a concern respectively. The maximum and mean ranges in soft and microspheres should be handled, like other radio- tissue are 11 and 4 mm, respectively. pharmaceuticals, as open sources. The purpose of this guideline is to assist the nuclear medicine physician in 2. Radioactive compounds treating and managing patients undergoing such treatment. – Ethiodized oil is a 38% iodine-rich fatty acid ethyl ester from naturally occurring poppy seed oil. Its . Keywords Guidelines Nuclear medicine Liver content of stable 127I is substituted with 131Iby . 131 . 131 . cancer I-Ethiodized oil I-Lipiodol Lipiocis® simple exchange reaction. 90 . Y-Microspheres SIR-Spheres® TheraSphere® – 90Y-microspheres (Table 1): Resin-based spheres . Glass spheres . Radiomicrospheres Resin-based microspheres are microspheres of acrylic polymer with a size between 20 and 90 Purpose 60 μm in diameter, in which Y is bound to the carboxylic group of the polymer after production The purpose of this guideline is to assist nuclear medicine of microspheres. specialists in: Glass microspheres are microspheres of glass with 20–30 μm of medium size, in which 89Y, embed- 90 1. Evaluating patients who might be candidates for ded in the glass matrix, is activated to Yina treatment using intra-arterial radioactive compounds nuclear reactor. for primary or secondary liver cancer 2. Providing information for performing this treatment 1 Additionally, it is important to notice a very small abundance of 3. Understanding and evaluating the consequences of this emitted positrons, since 90Y-microsphere imaging is possible on therapy positron emission tomography (PET) devices. Eur J Nucl Med Mol Imaging Table 1 Comparison of 90Y-microspheres Characteristics SIR-Spheres® TheraSphere® Material Resin Glass Particle size (μm) 20–60 20–30 Number of spheres per vial (range in million) 40–80 1.2–8 Specific gravity Low High Embolic effect Moderate Mild Activity per sphere (Bq) 40–70 2,500 Activity available (GBq) 3 3, 5, 7, 10, 15, 20 Handling for dispensing Required Not required Splitting one vial for two or more patients Possible Not possible Delivery route Transcatheter, intra-arterial (hepatic) Transcatheter, intra-arterial (hepatic) Hepatic ports (rare) Modified from Salem and Thurston [28] 3. Therapy trapped in the liver. A fraction of the administered activity distributes into normal liver tissue [5–7]. – In this context, therapy means the intrahepatic, In 90Y-microsphere therapy, pre-therapy intra-arterial intra-arterial administration of 131I-Lipiodol (Lip- 99mTc-labelled albumin macroaggregate2 (MAA) scintigra- iocis®) or 90Y-microspheres, i.e. SIR-Spheres® phy3 (see below) is mandatory to quantify potential liver- (resin spheres) or TheraSphere® (glass spheres). lung shunting and to exclude blood reflux to bowel, stomach or pancreas [8, 9]. Background The therapeutic efficacy of the method derives essentially from radiation as opposed to the ischaemia associated with The treatment of hepatocellular carcinoma (HCC) via the chemoembolization or pure embolization. The radiobiological hepatic arterial route is based on the existence of arterial effect results from beta irradiation which favours destruction tumoural hypervascularization. Tumours bigger than 2 cm of tumour cells surrounding microvessels containing a high in diameter draw more than 80% of their blood supply from radioactive ligand concentration [10–17]. the hepatic artery. Normal liver parenchyma draws more The main difference between glass spheres and resin than 80% of blood from the portal vein. Highly selective spheres is the activity in each sphere, being much higher tumour uptake can thus be achieved by delivery of in a glass sphere (about 2,500 Bq) at production time, radioactive compounds into the hepatic artery, which with respect to about 50 Bq in one resin sphere. represents almost exclusively the arterial supply to liver Commercially available vials of glass spheres contain tumours [1–4]. up to 20 GBq, while resin sphere ones up to 3 GBq. For Conversely, liver metastases may have variable vascu- the same desired activity, glass spheres probably have larity, from avascular hepatic cysts, to normal hepatic less embolic effect on microvessels, being injected in parenchyma, less vascularized metastatic lesions (i.e. colon, much limited number. Potentially, for the same chosen pancreas, breast), and finally hypervascular metastases (i.e. activity, the higher number of
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