AACE/ACE/ CBNE NUCLEAR MEDICINE COURSE OVERVIEW- 2013 J. Woody Sistrunk, MD, FACE, ECNU Radiation Safety Officer Jackson Thyroid & Endocrine Clinic, PLLC Jackson, Mississippi woodysistrunk@gmail.com AACE NUCLEAR MEDICINE COURSE Kansas City, Missouri August 17-24, 2013 2 NUCLEAR MEDICINE IN THE OUTPATIENT PRACTICE OF ENDOCRINOLOGY OUTLINE •History •Licensure •AACE Course•Equipment 3 Why Nuclear Medicine in Endocrinology? • WE ARE NOT GYNECOLOGISTS TREATING SPIDER VEINS WITH A LASER. • WE ARE NOT INTERNISTS PERFORMING ACCUPUNTURE. • WE ARE NOT FAMILY PHYSICIANS PERFORMING DEXA/ Bone Density. • WE ARE NOT OPHTHALMOLOGISTS INJECTING BOTOX. • WE ARE NOT ORTHOPEDISTS RUNNING A WEIGHT LOSS CLINIC. • WE ARE THYROID DOCTORS EVALUATING/ TREATING THYROID DISEASE. 4 NUCLEAR MEDICINE HISTORY • 1896 Henri Becquerel – Discovered “rays” from uranium. • 1897 Madam Curie – Named mysterious rays “radioactivity”. • 1903 Alexander Graham Bell – Suggested placing sources containing radium in or near tumors. – Occupation– “Teacher” 5 1920 • Thyroid disease was primarily a clinical diagnosis. • No commercial TSH assay until 1973. • Exophthalmic goiter was a significant concern to the medical minds of the day. • Mortality from hyperthyroidism far exceeded the mortality from thyroid cancer. • Personal Communication. 2005. Baskin, Gharib, Hay, Mazzaferri and Scholtz. 6 CHARLES H. MAYO 1918 • Stated he had 3 patients with exophthalmic goiter die from injections of boiling water into the goiter. • “They were treated in their beds to prevent shock, the water was probably not hot enough to coagulate albumin, and possibly more easily enabled the gland to throw off the hormones of secretion.” • JAMA September 14, 1918. 7 George Crile, MD Founder of the Cleveland Clinic • “If an individual with exophthalmic goiter could be made to hibernate like a bear, he would probably come out cured, for the driving mechanism, the brain, rests, then the organism as a whole rests; and if the rest is long enough, certainly the pathologic states tend to revert to the normal state.” 8 “EXOPHTHALMIC GOITER” • 1920s Methods of Treatment – Rest – Hydrotherapy • “A daily lukewarm bath is to be encouraged in every case…” – Gastrointestinal Hygiene • “After food is taken, an hour’s rest in an armchair..” – Mental Hygiene • “… all factors conducive to a state of excitation of the emotions are promptly to be eliminated.” • This included unannounced surgical dates.- or as it was called “Stealing a thyroid.” • Exophthalmic Goiter and Its Non-surgical Treatment. Israel Bram, MD. 1920 9 1931 External beam Radiation for Graves’ Disease. 10 RADIOACTIVITY? WHY, WHEN WE HAVE THE BMR??? 11 1938-Glenn Seaborg discovered I131 • • • • • 1951 Nobel Prize Recipient “We created isotopes that did not exist the day before, with uses yet to be discovered. One day a pioneer in nuclear medicine complained that his studies of thyroid metabolism were limited by the 25-minute half-life of the tracer he was using. When I asked what duration he needed, he replied, "Oh, about a week." Soon thereafter, my partner and I synthesized iodine-131, with a halflife of eight days. Iodine-131 is still widely used for diagnosis and treatment of diseases--and prolonged my own mother's life by many years. “ 12 HISTORY --1941-- Evaluation • Joseph Gilbert Hamilton, Mayo Soley and Robley Evans measured uptake giving 24-100uCi of radioactive iodine and 14 mg of sodium iodide orally. • A Geiger counter was placed over the thyroid and the proportion of the dose taken up by the thyroid was calculated. • THE BIRTH OF THE THYROID UPTAKE. 13 1941- A Truly Amazing DiscoveryTreatment of Hyperthyroidism. • Hertz, Roberts, and Chapman in Boston and Soley in San Francisco. • Initially used a mixture of 2 isotopes I131(T1/2= 8 Days) and I130(T1/2= 9 minutes). • Usual dose 14.5 mCi. • Chapman, E.M., and Evans, R.D. : Treatment of hyperthyroidism with radioactive iodine. JAMA 131:8691(May 11) 1946. 14 1946– Thyroid Cancer Therapy • Samuel M. Seiden • Leo D. Marinelli • Eleanor Oshry – Treated a patient with thyroid cancer with Iodine 131, an “atomic cocktail” 1945- 78 rpm JAZZ Slim Gaillard also wrote the “Penicillin Boogie” in 1945. 15 1947 American Association for the Study of Goiter George Crile, Jr. Discussing anti-thyroid drugs • “In closing, I should like to say that the mortality following operation for hyperthyroidism has been about 10 to 20 times that of simple goiter. • Unless a drug can be proved to result in mortality which is higher than the difference between the mortality of simple goiter and hyperthyroidism, I will continue to prepare the majority of patients for operation with antithyroid drugs.” • Little did he know that 131-I it would change it all forever. • P. 196 Transactions of the American Association for the Study of Goiter. 16 History of 131I Therapy • 1946-1970 – Endocrinology • 1970-1993 –Nuclear Medicine • 1993-Present –♠AACE Initiative 17 History— Nuclear Medicine Era • Missed diagnosis • Failure to discuss other treatments • Failure to discuss non-thyroid problems • Misadministration • Loss to follow-up • “Thyroid uptake is low consistent with hypothyroidism.” • “Thyroid uptake is low, r/o paraneoplastic process.” 18 Why Nuclear Medicine in Endocrinology? • Who knows more about the thyroid than an endocrinologist ?? • Making sure OUR patients are treated appropriately. • HORRORS: • “In that room you will find a box. In that box you will find a lead container. In that container is a pill. Take it and leave.” PUBLIC PERCEPTION 19 NUCLEAR ENDOCRINOLOGY LICENSURE/ DEFINITIONS 20 Agreement State vs. Non-Agreement State • Agreement State – A state that has signed an agreement with the Nuclear Regulatory Commission under which the state regulates the use of byproduct , source, and small quantities of special nuclear material in that state. • Non-Agreement State – The state is governed by the applicable laws of the Nuclear Regulatory Commission (NRC). Source: www.nrc.gov 21 What is a Radioactive Materials (RAM) License ? Issued to your clinic, or the hospital where you have privileges, by the NRC or Agreement State. Allows the facility to order, receive, possess and use radioactive materials. 22 Who is an Authorized User ? Authorized Users are physicians listed on the radioactive materials license who are authorized to prescribe and administer particular radiopharmaceuticals for specific diagnostic or therapeutic procedures. 23 What will I be able to do as an Authorized User of Radioactive iodine? 1. Thyroid Uptakes (I131, I123 ) NO SCANS 2. Radioactive Iodine (I131)treatment for Hyperthyroidism. 3. Radioactive Iodine (I131)treatment for thyroid cancer / thyroid gland ablation. NOTE: YOU WILL NOT HAVE THE ABILITY TO PERFORM THYROID SCANS. ******** 24 NO SCANS repeat NO SCANS • If you need a scan, Nuclear Medicine in your hospital can accommodate you. • 800 hours for the imaging part of the Nuclear Medicine License. Remember, If they don’t have a nodule is a scan much help?? 26 What Do I Have To Do To Become An Authorized User ? 80 hours of classroom instruction with an emphasis on radiation safety, physics and math. • AACE 80 HOUR COURSE. Board certification by a medical specialty board. Supervised treatment of 3 patients with less than 33 mCi. (Hyperthyroidism) Supervised treatment of 3 patients with more than 33 mCi. (Thyroid cancer). 27 Getting Licensed– POINTERS GET INTERESTED!!!!! • Transfer of License– – Fellows in Training can obtain a license or “User Status” in the training institution, then transfer the license upon completion. – Identify and meet with your institution’s Radiation Safety Officer. • Get to know a local licensee. – Ask AACE for help or call me. • Call your state agency, explain your desire for licensure, and ask for an application. – Remember, you are a TAXPAYER, and they are a state agency. • Call the Nuclear Pharmacy in your area. – Remember, they want your business. – They will help you to get your business. 28 How to Get Started • What to Know? • License requirements in your state. • Equipment required. • Layout of nuclear medicine hot lab. • Who to contact? • State nuclear regulatory agency • Physicist • Nuclear Pharmacy 29 NUCLEAR ENDOCRINOLOGY EQUIPMENT 30 So now it’s time to set up a HOT LAB! • WHAT WILL I NEED TO PURCHASE?? – Uptake System – Dose Calibrator – Geiger Counter • WHAT ARE THESE THINGS? 31 UPTAKE SYSTEM THYROID UPTAKE PROBE • Some are fancy • Some are simple • Some can make your life complicated or easy. • All based on 1940’s (or earlier) iodine crystal technology. 32 Variety of Uptake Systems $10,000-$14,000 COMPUTER BASED MOVEABLE WALL MOUNT SIMPLE “CALCULATOR” BASED, MOVEABLE DESK TOP MODEL 33 GEIGER COUNTER with Pancake Probe– COST $1000 DOSE ARRIVES IN TUNGSTEN PIG 34 NECK PHANTOM-- $275 • An “Artificial Neck” used to check the activity of a uptake capsule prior to administration. • Previously made of wood, these are characteristically now made of solid plastic, or filled with water. 35 DOSE CALIBRATOR $6500 • Necessary to verify that the dose ordered is correct. • This will no longer required by a new NRC ruling if “unit doses” are ordered. (Is this a good idea??) • “UNIT DOSE” is a specific dose (capsule) ordered and prepared for a specific patient. – These doses are prepared by injecting a capsule with liquid I131 (with an insulin syringe) until the desired dose is achieved. 36 Total Hot Lab Setup $20,000- $24,000 • Uptake System $10,000-$14,000 • Dose Calibrator $6000-$8000 • Neck Phantom $275 • Geiger Counter $1000 37 FILM BADGES $350/year 38 SIMPLE “HOT LAB” LAYOUT • Essentials include a sink and a few electrical outlets. • This can be the same room used for ultrasound exams. • The same stretcher can even be used. 39 SIMPLE “HOT LAB” LAYOUT SIMPLE “HOT LAB” LAYOUT SIMPLE “HOT LAB” LAYOUT SIMPLE “HOT LAB” LAYOUT Nothing this Fancy, Nothing this complicated. •No special leadlined room. •No special facilities needed. •But this is impressive!!!!!!!!! HOW MUCH EXPOSURE WILL I RECEIVE??– • Minimal !!! If any. • VERY SAFE♠♠ • HOW DO YOU KNOW IF YOU ARE EXPOSED?? • Film Badges. • WEEKLY Bioassay- which is simply placing the uptake probe over the neck will be performed weekly to confirm that radioactive iodine is not absorbed. 45 HOW TO INCORPORATE THYROID NUCLEAR MEDICINE PROCEDURES INTO AN OFFICE PRACTICE WEEKLY CALENDER 46 Tuesday • – Verify that all patients are scheduled and coming. Precertification with insurance company. Uptake Doses are ordered. 47 Wednesday • 7AM– Up and ready10-15 minutes – Uptake system calibration– 4 minutes – Dose calibrator calibration– 1 minute – Calibration of each dose and RX written. • Up to 10 minutes, depending on the number of uptakes. 48 BOX INSPECTION • Basically a verification that the dose received does not have any radioactive contamination on the packaging. 49 DOSE CALIBRATOR How does it work? 50 AUTOCALIBRATION 51 Wednesday • 8 AM Patients arrive. (7:30 if serum pregnancy test required) • Uptake Begins: – Background counts of thigh and Neck– 5 minutes. – Measuring capsule in Phantom, and room Background– 3 minutes – QUALITY MANAGEMENT PROGRAM (QMP) Papers, Verification of Pt. Name, SS # – Dose administered. 52 THYROID UPTAKE Background /Dose count / Uptake 53 Wednesday • Noon – Patients return for 4-6 hour readings. – 1 minute over thigh, 1 minute over neck. – Brief review of details with patient. – Room survey and wipe tests. 54 Thursday • 7:30 Arrive and calibrate uptake system and dose calibrator. (10 minutes) • 7:45 Patients arrive to complete the uptake, roughly 5 minutes per patient. • 8:30 Discussion with patients regarding treatment options. • 9:30 Treatments begin, allow 15 -20 minutes per patient. • Noon End of day assay and wipe tests. 55 Friday • • • • End of week survey/ wipe tests. Auto-callibration of uptake probe. Bioassay. 6 minutes or less. 56 DOCUMENTATION Yes, they will come looking! STORE YOUR RECORDS FOR EASY ACCESS!!!!!! • Be prepared for your first inspection!!!!! • Call other AACE members in your area to ask for pointers in preparation for inspection. • Ask your dose supplier and/or physicist for pointers or even a mock inspection. • It’s all about ORGANIZATION!!!! 57 WILL THIS PAY FOR ITSELF?? 3 UPTAKES/ MONTH= Paying for itself. • In practice almost 12 years. • 793 uptakes. • 893 I131 therapies. • ********Ultrasound procedures outnumber nuclear medicine procedures by about 15:1***************************************** ********* • ♠♠ THYROID ULTRASOUND CAPABILITY IS ESSENTIAL ♠♠ 58 Fellows: WHILE IN TRAINING • Pursue all of the requirements needed for licensure. • Review this talk with more detail at aace.com. • Get to know the radiation safety officer at your institution (who often times is not a radiologist) and try to be put on the institution license as an “official user”. 59 While Interviewing • Ask about the possibility of you having a “hot lab” and doing your own nuclear medicine procedures. • Make sure you have access to a good ultrasound machine. • Be specific with monetary figures, space requirement and the long term moneymaking potential. 60 CERTIFICATION BOARD OF NUCLEAR ENDOCRINOLOGY (CBNE) • IN PROGRESS WITH NRC. • Certification board to assist in the licensure process of endocrinologists using radioactive iodine in the assessment and treatment of thyroid disease. • ANOTHER STEP AACE /ACE HAS MADE IN PROMOTING NUCLEAR MEDICINE FOR ENDOCRINOLGISTS. 61 PATHWAY TO LICENSURE CASES 3 Hyper 3 cancer 80 hour AACE/DTC course ICANL Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories RAM LICENSE STATE/ NRC ICANL LAB CERTIFICATION 62 RECAP – CONCLUSIONS: Nuclear Thyroidology • A thyroidology practice is a career option. • Thyroid ultrasound will be a huge portion of the practice but Nuclear Thyroidology is another practice enhancement available. • Hyperthyroid and thyroid cancer patients are already nervous. Put their minds at ease as you are the administering doctor explaining treatment from start to finish with them. • RECOMMENDATION P: • Personal Experience: If I can do this, ANYONE can do this. CONCLUSIONS: • Thyroid Doctors treating Thyroid Disease. • With the Revised ATA guidelines, the internet savvy patient, and our ability to “know” the disease process, • Nuclear Medicine Physicians will be more than happy to give it back to us soon. • BE READY!!!!!!!!!!! AACE NUCLEAR MEDICINE COURSE Kansas City, Missouri August 17-24, 2013. 64 AACE NUCLEAR MEDICINE COURSE Kansas City, Missouri August 17-24, 2013 66 THE END • PLEASE E-MAIL ME IF I CAN HELP. • woodysistrunk@gmail.com