ALARA and Radiation Safety

Transcription

1 ALARA and Radiation Safety Experience the power of TheraSphere and deliver hope where it s needed most. Imagine where we can go. btg-im.com

2 What is TheraSphere? TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/ occlusion, when clinical evaluation warrants the treatment. 3 TheraSphere : Consists of insoluble glass microspheres where yttrium-90 ( 90 Y) is an integral constituent of the glass 3 Has a mean microsphere diameter of 20 to 30 μm 3 Is a pure beta emitter with an average energy of MeV and physical half-life of 64.1 hours (2.67 days) 3 Is calibrated to U.S. National Institute of Standards and Technology (NIST) standards 9 The recommended dose for TheraSphere administered to the liver is between Gy ( ,000 rad). 3, * TheraSphere dose vial Radiation exposure to the healthcare professional during TheraSphere treatment is well below the amount of exposure from a US coast-to-coast flight. 10,11 * Please refer the TheraSphere Package Insert for complete dosing calculations and administration instructions.

3 What is ALARA? Power Where You Need It As Low As Reasonably Achievable The use of radiation for beneficial purposes in medical procedures is a major contributor to improved human health. However, the benefits of treatment need to be balanced with the risks of radiation exposure. ALARA is a radiation safety principle of keeping unneccessary radiation exposure and release of radioactive materials to the environment as low as can be achieved by employing all reasonable methods. 1 ALARA is also a regulatory requirement for all radiation safety programs. ALARA is based on the assumption that exposure to radiation of any dose increases the probability of detrimental biological effects such as genetic mutations and cancer. ALARA can be achieved using three key factors: 1. TIME Reducing exposure time reduces radiation risk. 2. DISTANCE Doubling the distance reduces radiation exposure four-fold. 3. SHIELDING Shielding material absorbs radiation between the source and the individual. Adapted from Brateman L, ALARA = As Low As Reasonably Achievable

4 How Does the TheraSphere Dose Vial Conform to ALARA? TheraSphere was designed with ALARA in mind to reduce radiation exposure to both healthcare professionals and patients to As Low As Reasonably Achievable levels. Dose vials are ready to use 3 Both the shipping vial and the administration vial are ONE AND THE SAME NO dose preparation or manipulation is required Rapid infusion means that delivery is quick, with an infusion time of less than 5 minutes 4 NO continuous fluoroscopy or contrast is needed during administration 4 Preparation (priming) of the administration system tubing is performed independent of the dose vial 3 Protection is provided by acrylic and lead shielding around the dose vial during shipping AND patient treatment 3 Acrylic shield blocks 100% of the beta radiation 3 Lead pot reduces Bremsstrahlung radiation exposure to 1/7 th of levels without lead shielding 3,5 NO significant amount of free 90 Y present in the treatment vial 5 Minimizing radiation exposure to patients and others: NO significant amount of 90 Y leaches from the glass matrix 5 Secondary radiation exposure to others is well below regulatory limits 5 Body fluid radioactivity is NOT an issue for TheraSphere patients 5 There is NO need for special precautions regarding body fluids (urine, stool, blood, or vomit) Patient hygiene instructions are NOT necessary High delivery efficiency means less 90 Y in waste materials that need to be handled after patient treatment 4 90 Y = yttrium-90; ALARA = As Low As Reasonably Achievable

5 How Does the Administration Accessory Kit Conform to ALARA? The TheraSphere Administration Accessory Kit is designed and constructed to SHIELD healthcare professionals and patients from radiation exposure to As Low As Reasonably Achievable levels. TheraSphere Administration Accessory Kit: Provides 100% beta shielding to the user through the acrylic shield 3,6 Is supplied with a 2 L waste jar with beta shield for handling and storing post-treatment waste 3 Is designed to contain any potential leaks from the dose vial (although leaks are exceedingly rare) 7 Lead pot containing dose vial 2 L waste jar with beta shield Dosimeter Acrylic shield Administration Accessory Kit ALARA = As Low As Reasonably Achievable Adapted from the TheraSphere website: 8

6 Additional Product Information Indication for Use Authorized by Federal Law under a humanitarian device exemption (HDE) for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated. 3 Important Safety Information Caution Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training and experience. 3 Warnings A retrospective study of 121 patients from five clinical trials has shown that the following five Pre-treatment High Risk Factors have been associated with at least 48% of all serious adverse events that were possibly related to use of the device and with 11 of the 12 deaths that were possibly related to use of the device: Infiltrative tumor type Bulk disease (tumor volume >70% of the target liver volume, or tumor nodules too numerous to count) The physician should always take the above-noted Pre-treatment High Risk Factors into consideration for each patient when making decisions regarding the use of TheraSphere for treatment. 3 Contraindications The use of TheraSphere is contraindicated in patients: 3 whose Tc-99m MAA hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques who show shunting of blood to the lungs that could result in delivery of greater than 16.5 mci of yttrium-90 to the lungs. Radiation pneumonitis has been seen AST or ALT >5 ULN Bilirubin >2 mg/dl Tumor volume >50% combined with an albumin <3 g/dl in patients receiving doses to the lungs greater than 30 Gy in a single treatment in whom hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis who have severe liver dysfunction or pulmonary insufficiency who are pregnant Adverse Events The most common adverse events ( 5%) include elevated bilirubin (23.1%), ascites (8.3%), abdominal pain (6.6%), and elevated AST/ALT (5.8%). 3 Please see the full TheraSphere Package Insert available at for complete important safety information, including BOXED WARNINGS. References: 1. Canadian Nuclear Safety Commission. Regulatory Guide: Keeping Radiation Exposures and Doses As Low as Reasonably Achievable (ALARA). G-129, Revision 1, October Brateman L. Radiographics 1999;19(4): Package Insert TheraSphere Yttrium-90 Glass Microspheres Rev. 12. Biocompatibles UK Ltd, a BTG International group company. Available at: physicians-package-insert/ts_packageinsert_usa_v12.pdf. 4. Salem R, Thurston KG. J Vasc Interv Radiol 2006;17: U.S.A. TheraSphere Reference Manual (PCCS 550A). 6. McGhee S, Data on file, July 11, McGhee S, Data on file, July 3, BTG International Canada Inc. com. Accessed July 14, Cessna JT, communication, April 8, United States Nuclear Regulatory Commission (U.S. NRC). Measuring Radiation. Updated June 28, 2013; accessed July 22, McGhee S, Data on file, July 18, Hilgard P, Hamami M, Fouly AE, et al. Hepatology 2010;52(5): Mazzaferro V, Sposito C, Bhoori S, et al. Hepatology 2013;57(5): ALT = alanine aminotransferase; AST = aspartate aminotransferase; Tc-99m MAA = technetium-99m macroaggregated albumin; ULN = upper limit of normal Power Where You Need It Imagine where we can go. Humanitarian Device. TheraSphere is authorized by Federal Law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated. 3 Common adverse effects include fatigue, pain, and nausea. The majority of adverse effects are mild to moderate in severity and are manageable or resolve over time. For details on rare or more severe adverse effects, please refer to the TheraSphere Package Insert at 3,12,13 TheraSphere is manufactured for Biocompatibles UK Ltd, a BTG International group company. TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. Power Where You Need It and Power You Can Trust are trademarks of Biocompatibles UK Ltd. Imagine where we can go is a trademark of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. All rights reserved BTG International Canada Inc. US-USTHSP btg-im.com