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The Cyclotron Facility in Thunder Bay -How we got here and where we are going Mike Campbell, Ph.D. Director of Cyclotron Operations and Radiation Safety Officer Thunder Bay Regional Health Research Institute Why a Cyclotron in Thunder Bay • Research Institute started in 2007 with a focus on imaging • Making better imaging detectors (See it) • Developing more specific diagnostic agents (Tag it) • Using imaging to guide non-invasive surgery (Treat it) • 2008 TBRHSC Cancer Program commissioned a PET scanner • In order to meet patient needs and to support research, it was decided to bring a cyclotron to Thunder Bay. 2 So we are all on the same page... • What is a cyclotron and what does it do? • Proton accelerator • Not like in Ghost Busters... • Used to make relatively short-lived radioactive isotopes that can be used for medical imaging • Also requires supporting infrastructure such as radiopharmacy labs 3 What do cyclotrons make • The work horse isotope is Fluorine-18 (half-life ~110min) • However, to get that to find cancer, it must be incorporated into a drug that cancer cells take up faster than healthy cells. • The main example of this is FDG. • Radiolabeled glucose molecule that is metabolized by cancer cells 4 Thunder Bay’s Cyclotron • One of the challenges with having a PET scanner in Thunder Bay was getting the short-lived isotopes here. • Must navigate loss of activity due to radioactive decay • Material not arriving due to weather or flight cancellations • We don’t have the population base in NWO to survive by just making FDG for our local patient needs. Have to sell externally • Time and distance work against us for shipping things out just as it does for bringing things in • Need longer half-life products 5 6 7 Thunder Bay’s Cyclotron • We made the strategic decision to install a “larger” cyclotron in Thunder Bay. • Higher initial cost but... • Able to produce longer-lived isotopes. • Fluorine-18 and FDG still have same half-life (110 min) • Indium-111 (2.8 days) • Gallium-67 (3.25 days) • Iodine (13 hours) • Iodine-124 (4.2 days) 8 Before we started production... • Lots of planning and hair loss • Funding • Very fortunate to have strong support of: • The community • Federal Government (FedNor) • Provincial Government (NOHFC) • Municipal Government • Facility • Has to be able to operate safely • Radiation Safety – Workers, Public and Environment • Products for the patients 9 So we want to make radioactive materials in your neighborhood... • Working with the public and being open about everything we are doing is critical • As part of our licensing we initiated a Public Information Program (PIP) to let the public know what our plans were and to give them a chance to ask questions. • We have conducted over 20 public information sessions or invited talks in the community. • We have taken over 1500 people through the facility to show them what we do and the safety measures we have in place. • We wanted information on cyclotrons and radiation to come from us, not YouTube. • Support from the community has been exceptionally positive! 10 I so t o pes hav e d i f f er en t n u m ber s o f n eu t r oisn#1 s. Safety • A lot of work went into making sure all the safety systems work together during commissioning • Constant testing to make sure they continue to work Ju st l i k e so m e co o k i es hav e d i f f er en t u m bersafety s o f is cjust hoas coimportant l at e c hi ps... • nProduct • Need to be able to show we can consistently make a quality product • More importantly we have the controls in place to catch something if it goes wrong • Treat every dose as if it is going to a family member ...bu t co o k i es t a st e bet t er. 11 The Facility • Still in the early stages. • Just received our license to operate from the CNSC in February 2016. • Working to submit our license application to Health Canada for FDG. • Allow us to prepare doses for human use • Developing all the procedures to allow us to prepare radio- pharmaceuticals safely. 12 Cyclotron Bunker Equipment Room Research Lab Clinical Lab QA / QC Lab Shipping Support Spaces 13 Where are we now Class 7 – 352,000 p/m3 Normal room air ~35,000,000 Particles 0.5 microns or larger per cubic meter Class 8 – 3,520,000 p/m3 • Getting clean! Class 5 – 3,520 p/m3 We have achieved class 6 on both of our buffer rooms 14 Keep it clean • We spend a significant portion of our time cleaning • Clean and sanitize the production rooms • Mop from ceiling to floor • Sample surfaces to see if any bacteria is present • Sample the air to determine the number of bacteria per cubic meter • ISO Class 5 anything more than one bacteria colony per cubic meter the area fails. 15 Function over fashion 16 It’s the details... • ...That will ensure you succeed and that will drive you crazy. • It is the little things you never thing will be a problem that that will trip you up • Draft coming in around an electrical outlet that was causing clean room to fail classification • Vial 4mm too tall to fit in lead shipping container. Needed to have new holder printed 17 Most important asset • People • Training and repetition of tasks to ensure competence • Safety and quality can never be compromised “Treat each dose as if you are preparing it for a family member.” 18 What will having a cyclotron in Thunder Bay do for us? • Most important thing is we will be able to meet local patient needs for FDG. • Research • We want to go beyond the information that FDG provides. • FDG is excellent at answering the question, “Is there cancer?” • Not so good at answering “What drug should we use to treat the cancer?” 19 What additional information can we get? • The information we can receive from FDG is similar to a black & white photo. • It tells us cancer is present but doesn’t tell us which drug to use to treat it. 20 What additional information can we get? • Can we get more information (colour) with other imaging agents? • Can we create radio-labeled versions of different chemotherapy agents to answer the question “Which drug should we use?” 21 Use of PET to help guide therapy • Add to the value of the scan • For a drug to be able to kill a tumour it needs to be able to get to the tumour • Drug A • Drug B 22 For more information • Including photos, virtual tours and information of future public tours and information sessions please visit www.TBRHRI.ca • Click on the cyclotron tab [email protected] 23 Thank you! • The team from the cyclotron facility • Terry Fodë • Bozin Nedanovski • Jesse Walker • Sonja Desjardins • Melissa Quance • TBRHSC Foundation • FedNor • NOHFC • City of Thunder Bay 24 25