sirtex dose calculator

PDF SIRTEX MEDICAL INC. 300 Unicorn Park Drive Woburn, MA ... Dose calculation considerations for both products have been previously summarized in this report. J Vasc Interv dose deposition kernel by using 90Y time-of-ﬂight posi- Radiol 2014; 25:1085-1093. How SIR-Spheres® Y-90 resin microspheres can improve ... The patient dose is dispensed on-site in the nuclear pharmacy . Calculation dose of Sirtex therapy. About Sirtex Medical Sirtex Medical is a global healthcare business with offices in the U.S., Australia, Germany and Singapore, working to improve outcomes in people with cancer. Sirtex Medical Limited is a US Based company with an approved cancer treatment supplied globally. Theraspheres. (PDF) The Limitations of Theoretical Dose Modeling for ... Retrospective creation of post‐TARE image‐based dose distributions for ten patients treated with SirTex SirSpheres TM 90 Y microspheres for hepatic malignancies at Wake Forest Baptist Medical Center. The technique was first introduced by Ariel, who also . PDF 1. DESCRIPTION t - radmed.com.tr Revenue: $100 to $500 million (USD) Competitors: Unknown. SIR-Spheres® is a device consisting of radioactive microspheres. PDF Journal of Cancer Science & Therapy Open Access • After the scan you will be moved back to the Angio day ward before you can go home. Comparison of posttherapy 90Y positron emission tomography ... HOW I DO IT: SIRT for Hepatocellular Carcinoma TheraSphere™ Y-90 Glass Microspheres - Ordering ... SU-E-T-02: 90Y Microspheres Dosimetry Calculation with ... The SIR-Spheres Microspheres Activity Calculator ("SMAC") is intended as a tool to assist with personalized dose activity calculations, based on relevant patient data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. The dose is calculated by using a conversion factor opioid dose multiplied or divided by factor = morphine dose . Y-90 activity calculation The partition model is a validated and scientifically sound (MIRD) method of radionuclide internal dosimetry for Y-90 microspheres. Moreover, radiobiologic models for both tumor control Empirical dose calculation Body surface area (BSA) Partition model Simple. A total of 23 SIRT procedures from 18 ICC subjects were analysed to determine a lesion-based dose/response relationship with absorbed dose measures from 90Y PET and metabolic response as measured . . In current clinical practice, the transfemoral implant is widely used. WOBURN, Massachusetts, Feb. 12, 2020 /PRNewswire/ -- Sirtex Medical announces collaboration with MIM Software Inc. 4 ) 25 , 26 . The radiation dose delivered to the liver by 90Y-microspheres is50 Gy (5,000 rad) for 1 GBq (27 mCi) per kilogram oftissue. SIRTEX MEDICAL INC. 300 Unicorn Park Drive Woburn, MA 01801 Tel: +1 (781) 721 3800 Fax: +1 (781) 721 3880 Ref: 105US03 March 30, 2016 Frank A. Masino, M.D. The technology also incorporates CT, PET, SPECT and MRI . Assay and record the activity of the SIR-Spheres . Therapy with 90 Y-microspheres is emerging as a mainstream treatment modality in the management of patients with primary and metastatic liver cancer (1,2).The technique involves the administration of 90 Y-microspheres into the hepatic artery, which is accessed via the transfemoral route or through a hepatic arterial infusion port or pump. Calculation from Calibration (18:00 Eastern Standard Time) to Assay Time Hours Before Cal Decay Factor Total Activity Million Spheres per GBq 1:00 AM 65 2.020 6.06 7.3 64.5 2.009 6.03 7.4 2:00 AM 64 1.998 5.99 7.4 63.5 1.987 5.96 7.5 . scaling (LDM) and our own dose convolution method (WFBH), both applied at the voxel level. calculation and . TheraSphere™ Y-90 Glass Microspheres: How it's Made. By Marta Cremonesi and Amalia Dia. For 38 consecutive quarters, dose sales of 'SIR-Spheres', a medical . The dose is calculated by using a conversion factor opioid dose multiplied or divided by factor = morphine dose . That is, That is, b) Using aseptic technique in the Laminar flow hood, withdraw patient specific dose from the SIR- Spheres shipping vial. tumor dose-response curves not well developed AAPM 2015 S. Cheenu Kappadath, PhD 33 90Y -Therapy Planning: SIR Spheres SIR-Spheres therapy doses are based on activity (not target radiation dose) - maximum activity of 81 mCi Average liver dose < 80 Gy and lung dose < 25 Gy Dosimetry Models: Empirical or BSA . The second stage is dedicated to the assessment Y-90-SIRTex uptake in liver tumors and to exclude extra hepatic leak. SIR-Spheres ® is a registered . [] Sirtex Calc Written Directive and Sirtex Calc Written Directive -formsprinted from a spreadsheet that serves as a dose calculator and a pre-and post-administration written directive SirTex Microspheres -Section 23, pages 27-31 of the Cancer Center Policy and Procedures Manual Reporting Medical Events-pdf Section 22, pages -16 of the divide the morphine . Check that the reading is within +/-lo% of 3.0 GBq (81 mci). TheraSphere iDOC™ Tool. SIR-Spheres ® Y-90 resin microspheres is the only SIRT that offers the following: Customized dosing for each clinical situation. ical Limited; www.sirtex.com) treatment in HCC. MIRD - Simple, single model Methods. The remaining 4 cases also had a 99m Tc-MAA SPECT/CT pre-treatment simulation, but the activity planning utilized a semi-empirical body surface area (BSA) methodology such as provided by an online Sirtex dose calculator . Allows you to administer tailored activity for your patient-specific needs. It has two components, the microspheres and yttrium. The guide is colour coded as a visual prompt: . Not yet a big business, nor one that is widely held or covered by the investment community, we believe it has very bright prospects. Equianalgesic doses of oral opioids . Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. Methods: Spatial dose distributions and dose in liver and tumor are calculated for RE patients treated with Sirtex Medical miscrospheres at our center. xOnce the correct activity has been drawn up, transfer the SIR-Spheres microspheres from the 5ml syringe into the vented v-vial in the acrylic v-vial holder. In clinical settings worldwide, dosimetry for 90 Y RE is typically calculated using simple, semi-quantitative software provided by vendors. The 90 Y dose calculation used the local deposition method (LDM), 20, 21 which was previously demonstrated to be the most accurate when using SPECT imaging. Radioembolization is a valuable therapeutic option in patients with unresectable intrahepatic cholangiocarcinoma. Example Lung Shunt Calculation - SIR-Spheres: LS < 10% (no modification) 81 mCi 90 Y activity limit - TheraSphere: 30 Gy lung dose limit 222 mCi 90 Y activity limit LS (%) = Lung GM-counts / (Lung GM-counts + Liver GM-counts) x 100 = 77278 / (77278 + 973962) x 100 = 7.35% S. Cheenu Kappadath, PhD 12 90 Y-Therapy Planning: SIR-Spheres of higher prescribed doses, consequently transitioning radioembolization from palliative to curative therapy. The 90 Y-PET/CT was useful to confirm the hepatic distribution of microspheres and to calculate the average absorbed dose and the 3D distribution of the absorbed dose within each tumor. Transarterial radioembolization (TARE) effectively treats unresectable primary and metastatic liver tumors through intra-arterial injection of Yttrium-90 (90 Y) beta particle emitting microspheres which implant around the tumor.Current dosimetry models are highly simplistic and there is a large need for an image-based dosimetry post-TARE, which would improve treatment safety and efficacy. SIR-Spheres® is indicated for the treatment ofunresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) ofFUDR (Floxuridine). Using the BSA formula, the SMAC automatically performs III. Clin Nucl Med 2013 On the basis of posttreatment 3-dimensional activity distribution and Monte Carlo dose voxel kernel calcula-tions, the dose distribution was used to calculate the mean dose to healthy liver and tumor in each patient. The aim of this study was to investigate the safety and efficacy of selective internal radiation therapy (SIRT) with 90Y resin microspheres for the treatment of Intrahepatic Cholangiocarcinoma (ICC). This online tool will assist you in calculating and ordering the appropriate TheraSphere absorbed dose vial size based upon the desired dose, timing of administration, lung shunt fraction, anticipated residual waste and previous dose to the lungs. calculation and . Normally, each resin vial has a standard activity of 3GBq and a range of 30-50 million microspheres [2,4]. dose by the conversion factor. "Previously, the usual sequence of events was to map, do the dose calculation, order the dose and then treat," notes Kamel. transfer the SIR-Spheres microspheres back into the shipping vial and redraw the necessary volume of SIR-Spheres microspheres (either less or more). This is a radiotherapy treatment for primary liver cancer - hepatocellular carcinoma (HCC) Therapeutic approach. 5.4 CALCULATION OF INDIVIDUAL DOSE . The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations , based on relevant patient data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres . Lung dosimetry, unfortunately, has not seen the same advances in dose calculation methodology and renewed consensus in dose limits as normal liver and tumor dosimetry. Doctors and Medical Physics to reach accurate calculate dose. SIRTEX Microspheres are millions of little resin "beads" The . • This scan will be used to calculate the correct dose that you will need for your treatment. Activity of SIR-Spheres® < 10% Deliver full amount of SIR-Spheres® 10% to 15% Reduce amount of SIR-Spheres® by 20% 15% to 20% Reduce amount of SIR-Spheres® by 40% > 20 % Do not give SIR-Spheres® 5.4 CALCULATION OF INDIVIDUAL DOSE There are three accepted methods for calculating the patient After Sirtex Medical Limited's (ASX:SRX) share price rallied to $13.24 yesterday, the company's market capitalization reached $640m. Millions of tiny glass beads that are between 20 to 30 um in diameter contain 90 Y. 90 Y-PET/CT and contrast-enhanced CT scans were processed by using a dosimetry software (Simplicit90Y, Mirada Medical, Oxford, UK). Refer to the SirSpheres dose drawing chart located in the hot lab. 8.1.2 Identifying the Specific Risks of SIR-Spheres Microspheres ... 28 8.1.3 Identifying the risks of combining SIR-Spheres microspheres with STX0206 - SIRFLOX study, Version 10, August 2011 For those done using SIR-Spheres, the body surface area (BSA) method is primarily used;[] for TheraSphere treatments, activity in GBq is given as a product of dose (Gy) and mass (kg), divided by 50. If you are unsure how to properly draw a Y-90 SIR-Spheres dose, then DO NOT. (B) CT scans of the same patient prior to and (C) after therapy with Y-90 SIR-Spheres demonstrating mild decrease in size of the largest liver . Dosimetric calculation. DOSE BK Y90 is a multipurpose software based on Matlab programming language which features registration, 2D visualization, . dose (boost) to the targeted tumor with the intent to deliver a complete pathologic response.15 DOSIMETRY: NEW CONCEPTS AND TOOLS The standard method for dosimetry is the body surface area (BSA) model for resin radiomicrospheres (SIR-Spheres, Sirtex Medical Inc.) and the medical inter-nal radiation dose (MIRD) model for glass radiomicro- SIR-Spheres are more widely used, and the company is duly poised for continued growth. The formulas to calculate the treatment dosage are described in the Sirtex Medical train- SIR SPHERES DOSE CALCULATION • The dose was calculated using the body surface area (BSA) calculation formula: Radioactivity Required (GBq) = (Body Surface Area - 0.2) + Tumor Involvement BSA (m2) = 0.20247 * height (m)^0.725 * weight (kg)^0.425 Our 5'10", 230lb patient's BSA is calculated to be 2.22 Device Description . Its current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. Same day dose draw. Absorbed dose is the fundamental quantity defined as the mean energy imparted by the radiation per unit mass. SIR-Spheres ® resin microspheres can be implanted via the hepatic artery in one of two ways: (1) an implanted catheter with port, or (2) transfemorally. MIM SurePlan LiverY90 provides timesaving tools for liver and tumor segmentation and allows for patient-specific dose calculation on Y-90 PET and Bremsstrahlung SPECT images after administration of permanent Y-90 microsphere implants . 0 Record dose calibrator reading.Calculate from actual reading what the reading would be at the calibration time on the label. "However, utilising Sirtex's Order-Map-Treat programme, you get a much faster patient treatment." "We know that we can always draw the exact dose we want and that is the beauty of this. There are three accepted methods for calculating the patient PURPOSE To study the impact of transarterial Yttrium-90 radioembolization (TARE) in combination with second-line systemic chemotherapy for colorectal liver metastases (CLM). More than 100,000 doses have been supplied to treat patients with liver cancer . Dosimetry calculation. a) Place shipped vial of SIR-Spheres in dose calibrator and determine the calibration factor needed to obtain the activity specified on the shipping label. TheraSphere's unique ability to deliver high dose radiation with fewer spheres allows for maximum absorbed dose, and increased tumor response while . TheraSphere iDOC is an interactive Dose Ordering Calculator that will assist in calculating and ordering the appropriate TheraSphere™ dose vial size. Dose-Response correlation in colorectal cancer liver metastases (Resin spheres, administered activity according to BSA) AF. Therefore, the efficacy of curative radioembolization may be compromised in patients where the current lung dose . DOSE CALCULATION Theraspheres -Activity Required (GBq): [Desired Dose (Gy)][Liver Mass (kg)]/50 -Do not exceed 610 MBq to the lungs -30 Gy single session or 50 Gy cumulative Sirspheres -empiric, BSA and partition models -less than 10% lung shunting: no reduction -10-15%: 20% reduction -15-20%: 40% reduction Radioembolization of Hepatic Lesions from a Radiobiology and Dosimetric Perspective. Each patient had a bremsstrahlung SPECT/CT (parameters shown in Table 1) utilizing a Philips Healthcare TM scanner following SIR‐Spheres® implantation. J Nucl Med 2016; 57:1014-1019 Insights into the Dose-Response Relationship of Radioembolization with Resin 90Y-Microspheres: Table 1: The empirical method of Y-90 SIR-Spheres dose calculation. Under the terms of the agreement, Sirtex's sales teams in the USA, Europe, and other key global markets will offer MIM SurePlan LiverY90 software alongside the company's SIR-Spheres Y-90 resin microspheres to improve treatment precision for patients with hepatic tumours. The guide is colour coded as a visual prompt: . van den Hoven et al. Offering 3 different delivery options, 5 days a week, to suit your treatment schedule. divide the morphine . Through the process of creating dose dis-tributions, the emission image was scaled based on actual delivered activity at the time of treatment. Absorbed dose calculation To calculate the dose distribution in the cell cultures with a varying number of 90 Y-microspheres administered in the sample, the FLUKA code was used (Fig. Is there any activity I should avoid doing 0 Place piglet containing the shipping vial behind shield, pull back perforated aluminum cap with tweezers and wipe septum with alcohol swab. Over 100,000 doses of SIR-Spheres Y-90 resin . At this stage the purpose of the study will be to investigate the added value of SPECT-CT in the estimation of Tc-99m-MAA uptake in tumor lesions. Sirtex Medical has announced a collaboration with MIM Software. As a precaution, all HCC patients are considered to have an LSF of 10%, while liver metastases would have an LSF of 5%. SIR-Spheres ® is supplied as a 3 GBq ± 10% dose, calibrated on the planned treatment date, and can be used up to 24 h after calibration. The software allows physicians to quickly calculate the dose delivered by the microspheres to improve treatment decisions and patient care. Sirtex SIR-Spheres Pty Ltd, "SIR-Spheres® microspheres Training Program for Physicians and Institutions", Sirtex Medical Training Manual, . Administered directly to a vascular tumor. Its current lead . MIM SurePlan LiverY90 provides timesaving tools and post-treatment dosimetry for interventional radiologists and nuclear medicine physicians treating hepatic tumors with SIR-Spheres. Selective Internal Radiation Therapy (SIRT or radioembolisation) is an innovative radiation therapy for mCRC, which involves the delivery of SIR-Spheres® (Sirtex Medical Limited, North Sydney, Australia), that contain the β-emitter yttrium-90, into the arterial supply of the liver. SIR-SPHERES Assay and Dose Preparation THERASPHERE Assay and Dose Preparation MFRG MDS NORDION SIRTEX SIR-SPHERES Assay and Dose Preparation(DOSE 2 FROM VIAL 1) Vendor Certified Activity cc in Vial EXP pw;physics test RECORD ACTIVITY d test test 0.00 test 0.90 10.00 11.00 14.40-23.61 1.00 100.00 d d 3.48 2.77 11/5/2013 3:00:00 PM 11/5/2013 3:00 . The calculations are based upon the desired absorbed dose, timing of administration, lung shunt fraction, anticipated residual waste, and previous dose to the lungs. SIR-spheres range from 20 to 60 µm with an average activity of 50Bq per microsphere. Target dose is estimated by the nuclear physicist using volumetric data obtained from the 3D reconstruction of baseline cross-sectional imaging. Figure 1: (A) SPECT-CT Fusion Images demonstrating the Y-90 SIR-Spheres distribution around liver metastases from islet cell cancer. Within the LDM model, the nor-malization and dose calculation is based on counts found within the liver contour. Highlights between the two differing microsphere products can be seen in the European Association of Nuclear medicine (EANM) guidelines [5]. 2. Contact the department supervisor. Sirtex's main commercialised product is a targeted radioactive treatment for liver cancer called SIR-Spheres® Y-90 resin microspheres. SIRT Dose Calculation SIR-Spheres Dose (GBq) =BSA (m2) - 0.2 + volume tumour volume tumour + liver % Lung Shunting % Dose Reduction 0-10 % 0 % 10-15 % 20 % 15-20 % 40 % 40% Coldwell Reduction (before 7/2006) 25% Coldwell Reduction (after 7/2006) Volume reduction Post-Therapy Y-90 Bremmsstrahlung Scan Anterior Posterior Anterior Posterior Equianalgesic doses of oral opioids . It consists of radioactive yttrium oxide-aluminosilicate glass . Limitations of body surface area-based activity calculation for be computed by a three-dimensional convolution of a radioembolization of hepatic metastases in colorectal cancer. Place the V-Vial in the "Mayo Jar" center the jar on the Sirtex dose measuring chart. Sirtex Medical is a global healthcare business with offices in the U.S., Australia, Germany and Singapore, working to improve outcomes in people with cancer. Once SIR-Spheres microspheres are implanted into the liver, it is not metabolised or excreted and it stays permanently in the liver. The recommended dose to the portion of the liver to be treated is between 80 and 150 Gy. If percent lung shunting is >10% then there is need for dose INTENDED USE SIR-Spheres microspheres are intended for implantation into Based on those estimates, a provisional lung dose can be calculated, and . FLEXdose Delivery Program. SIR SPHERES DOSE CALCULATION • The dose was calculated using the body surface area (BSA) calculation formula: Radioactivity Required (GBq) = (Body Surface Area - 0.2) + Tumor Involvement BSA (m2) = 0.20247 * height (m)^0.725 * weight (kg)^0.425 Our 5'10", 230lb patient's BSA is calculated to be 2.22 2. TheraSphere is the most efficient and powerful HCC therapy that safely delivers high dose radiation with optimal patient outcomes. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. However, it can't be said the market is ignorant of the potential, and the company is quite expensive, though there was a decent opportunity to buy after the company reported subdued dose sales growth of just 4% for the first quarter of 2014. The software allows physicians to quickly calculate the dose delivered by the microspheres to improve treatment decisions and patient care. The common SI unit for radioactivity is the becquerel (Bq), which is commonly measured in gigabequerel (GBq) in TARE, but also referenced as millicurie (mCi). Data obtained from the previous simulation of treatment were the basis for calculations: Tc-99m maggregated albumin SPECT-CT study in a gammacamera (Infinia, General Electric Healthcare. Treatment volumes . - Easy to calculate - Can consider dose reductions based on LSF - Model recommended by SIRTex resin microspheres - Limited personalization - No consideration of tumor dose based on ratio of tumor to normal liver tissue - Y90 activity limited to 1.0-3.0 GBq - Tumor radiation dose is unknown - Possibility to undertreat. ). to calculate Percentage of Lung Shunting •Lung shunt fraction should be studied as soon as possible after injecting in the target heaptic artery •Delay scan: -Increased breakdown of MAA in liver higher lung shunt + systemic uptake -Wrong dose calculation De Gersem R et al. Liver Selective Internal Radiation Therapy with 90Y resin microspheres: Comparison between pre-treatment activity calculation methods. The activities were calculated considering the absorbed doses (Gy) by tumor and healthy parenchyma as proposed by Gil-Alzugaray [].These absorbed doses were defined by formula [] using the parameters obtained in the 99m Tc-MAA-SPECT/CT and CECT studies.In general terms, in cirrhotic patients with a predicted spared volume less than 40%, the activity was estimated to . 90 Y-Radioembolization (RE) is an established treatment modality for patients with unresectable hepatic malignancies [1,2,3,4]. The second commercially available product labeled with 90 Y is TheraSphere ®. Spheres microspheres than the normal liver. The essential implementation of the absorbed dose calculation methods should take . The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy . Dis-Tributions, the nor-malization and dose calculation methods should take 99mTc-MAA-SPECT/CT and Cone-Beam CT... < /a > Dosimetric.! 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( a ) SPECT-CT Fusion Images demonstrating the Y-90 SIR-Spheres dose, then not., Sirtex Medical Limited is a multipurpose software based on those estimates, a provisional lung dose contain! Sirtex Medical Limited is a US based company with an approved cancer treatment supplied.. Methods should take deposit all energy locally with the same voxel is widely used the same.. That offers the following: Customized dosing for each clinical situation and Cross-Sectional... < /a > Dosimetric.... Exclude extra hepatic leak efficacy and safety of combining FOLFOX-based chemotherapy with Selective internal radiation therapy for liver cancer SIR-Spheres®... Simplicit90Y, Mirada Medical, Oxford, UK ) 30-50 million microspheres 2,4... Products can be seen in the liver to be treated is between 80 and 150 Gy is... Perforated aluminum cap with tweezers and wipe septum with alcohol swab simple, semi-quantitative software provided by vendors with. 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Actual delivered activity at the time of treatment be moved back to Angio... And MRI calculation considerations for both products have been previously summarized in report... ; Mayo Jar & quot ; center the Jar on the Sirtex dose measuring chart the! Chemotherapy with Selective internal radiation therapy for liver cancer this is a multipurpose software based on actual delivered at! Of the absorbed dose calculation methods should take liver tumors and to exclude extra hepatic leak powerful therapy... Compromised in patients where the current lung dose lead product is a targeted radiation therapy dose sales of & x27! Days a week, to suit your treatment that offers the following: Customized dosing each.