Slide 1:Cardiac Perfusion (Resting Test) By: Tina Wall


Objectives :Objectives Discuss the different section of the MSDS Sheet Review Tl201 packet insert Discuss method if administration and indications List patient contradictions Describe patient preparation Discuss the equipment Describe the procedure List the normal and abnormal results List patient question to help obtain patient history


Slide 3:MSDS Sheet THALLOUS CHLORIDE TI 201 SECTION 1: CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product Name: Thallous Chloride Tl 201 Injection Synonyms: Thallium Chloride, Thallium-201 Revision Date: January 1, 2003 Manufacturer: Mallinckrodt Inc. 2703 Wagner Place Maryland Heights, MO 63043 Information Telephone Number: (888) 744-1414 Emergency Telephone Number: (314) 654-7860


MSDS Sheet THALLOUS CHLORIDE TI 201 :MSDS Sheet THALLOUS CHLORIDE TI 201 SECTION 2: COMPOSITION, INFORMATION ON INGREDIENTS Chemical Ingredients: Component CAS # Wt % Thallous Chloride Tl 201 55172-29-7 0.001% Sodium Chloride 7647-14-5 0.9% Benzyl Alcohol 100-51-6 0.9% Water 7732-18-5 ~99%


Slide 5:SECTION 3: HAZARDS IDENTIFICATION Inhalation: Thallous Chloride does not easily become airborne. Not expected to be a health hazard via inhalation. Eye Contact: No adverse effect expected, but may cause mechanical irritation. Ingestion: May cause asymptomatic physiological uptake by specific target organs or tissues. Skin Contact: Not expected to produce any acute adverse health effects. Chronic Exposure: The health risks associated with chronic radiation exposure are believed to involve levels of radiation exposure which are much higher than those permitted occupationally.


Slide 6:SECTION 4: FIRST AID MEASURES Inhalation: Notify radiation safety personnel immediately. The amount of material inhaled should be assessed and documented. Ingestion: Notify radiation safety personnel immediately. The amount of material ingested should be assessed and documented. Skin Exposure: If skin contact occurs, wash the affected area thoroughly with soap and water until no more radioactivity can be removed. Always blot dry. Notify radiation safety personnel. Eye Exposure: If a splash occurs, wash eyes with water for at least 15 minutes or until no more radioactivity can be removed. Notify radiation safety personnel.


Slide 7:SECTION 5: FIRE FIGHTING MEASURES Fire Extinguishing Media: Use any means suitable for extinguishing surrounding fire. Special Instructions: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. SECTION 6: ACCIDENTAL RELEASE MEASURES If the product is received in a leaking condition or any loss or release of the radioactive contents occurs, notify your Radiation Safety Department. Performed cleanup according to the Standard Operating Procedures.


Slide 8:SECTION 7: HANDLING AND STORAGE Store at 15°C to 30°C Handling time should be kept to a minimum. Handling devices such as syringe shields and tongs should be used. Storage and disposal of product should be in compliance with the regulations of the federal or state government agency authorized to license the use of this radionuclide.


Slide 9:SECTION 8: EXPOSURE CONTROLS, PERSONAL PROTECTION Airborne Exposure Limits: NRC Occupational concentration limit is 9 x 10-6 µCi/mL of air. Engineering Controls: Properly sealed containers are not expected to require any special ventilation. Skin Protection: Disposable plastic, latex, or rubber gloves; lab coat. Eye/Face Protection: Safety glasses. Precautions: No smoking, eating, or drinking should be allowed in any area where radioactive materials are handled or stored.


Slide 10:SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Appearance: Clear, colorless liquid in a 10 mL glass vial Odor: Odorless Solubility: Soluble in water Boiling Point: 100°C (212°F) Melting Point: 0°C (32°F) Radioactivity: 2, 4, 8 or 9 mCi/vial on the calibration date and time Concentration: 1 mCi/mL on the calibration date and time Specific Activity: 213 mCi/ µg of Thallium on the calibration date and time. Half-Life: 73.1 hours


Slide 11:SECTION 10: STABILITY AND REACTIVITY Stability: Stable under ordinary conditions of use and storage Hazardous Decomposition Products: May emit radioactive fumes containing TI-201 when heated to decomposition SECTION 11: TOXICOLOGICAL INFORMATION Exposure to sufficient quantities of ionizing radiation can potentially cause harmful biological effects which include cancer, leukemia, and genetic and teratogenic effects.


Slide 12:SECTION 12: ECOLOGICAL INFORMATION Treated by standard wastewater treatment facilities with no adverse environmental impacts SECTION 13: DISPOSAL CONSIDERATIONS Thallous Chloride Tl 201 is radioactive waste until the activity has decayed to nondetectable levels. Medical waste, such as blood, blood products, or sharps, the waste must be handled as a Biohazard and disposed of accordingly.


Slide 13:SECTION 14: TRANSPORT INFORMATION Proper Shipping Name: Radioactive Material, n.o.s. Hazard Class: 7 Identification Number: UN2982 SECTION 15: REGULATORY INFORMATION CERCLA Reportable Quantities: TI 201= 1000 Ci (3.7 E 13 Bq) Releases to air, land or water of these hazardous substances which exceed the Reportable Quantity (RQ) must be reported to the National Response Center at 800-424-8802. California Proposition 65 Warning: This product contains a substance known to the State of California to cause cancer. WHMIS: This MSDS has been prepared according to the hazard criteria of the Controlled Products Regulations (CPR) and the MSDS contains all of the information required by the CPR.


Slide 14:SECTION 16: OTHER INFORMATION MSDS Status: Revised in accordance with ANSI Guideline Z400.1-1998 NFPA Ratings: Health: 1 Flammability: 0 Reactivity: 0 Product Use: Diagnostic imaging agent Revision


Slide 15:Packet Insert Thallium 201 DESCRIPTION Supplied in isotonic solution as a sterile, nonpyrogenic, diagnostic radiopharmaceutical. Each unit dose contains 1 ml and each ml contains 37 MBq (1 mCi) of Tl 201 at calibration time. pH is adjusted to 4.5-7.5 with hydrochloric acid or sodium hydroxide. Tl 201 is cyclotron produced with no carrier added. Radionuclidic composition at calibration time, expressed as percent of total activity, is not less than 98%. It is recommended that Tl 201 be administered close to calibration time to minimize the effect of higher levels of radionuclidic contaminants pre and post calibration.


Slide 16:PHYSICAL CHARACTERISTICS Tl 201 decays by electron capture to Mercury Hg 201. Physical half-life of 73.1 hours. Lower energy x-rays obtained from the Mercury Hg 201 daughter of Tl 201 are recommended for myocardial imaging because the mean %/disintegration at 68.9-80.3 keV. EXTERNAL RADIATION Specific gamma ray constant for Tl 201 is 3.21 micro coulombs/hr-kg-MBq (0.46 R/hr-mCi) at 1 cm. First half-value layer is 0.023 cm of lead.


Slide 17:CLINICAL PHARMACOLOGY Tl 201 Injection with no carrier added has been found to accumulate in viable myocardium. In clinical studies, thallium images have been found to visualize areas of infarction as "cold” regions which are confirmed by electrocardiographic and enzyme changes. Regions of transient myocardial ischemia corresponding to areas perfused by coronary arteries with partial stenoses have been visualized when thallium was administered in conjunction with an exercise stress test. Blood clearance of Thallous Chloride Tl 201 Injection is primarily by the myocardium, kidneys, thyroid, liver and stomach. Tl 201 Injection is excreted slowly and to an equal extent in both feces and urine.


Slide 18:INDICATIONS AND USAGE Tl 201 is useful in myocardial perfusion imaging for the diagnosis and localization of myocardial infarction. Tl 201 may also be useful in conjunction with exercise stress testing Tl 201 is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels. Useful in pre-operative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for post-surgical reexamination.


Slide 19:WARNINGS Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus. If contents of a vial are radioactive, adequate shielding of the preparation must be maintained at all times. PRECAUTIONS Data are not available concerning the effect on the quality of Tl 201. Attention is directed to the fact that thallium is a potassium analog.


Slide 20:General Do not use after the expiration time and date (5 days maximum after calibration time) stated on the label. Rradioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should be taken to minimize radiation exposure to patients in a manner consistent with proper patient management. Radiopharmaceuticals should be used only by- Physicians who are qualified by training and experience in the safe use and handling of radionuclides. And whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.


Slide 21:Carcinogenesis, Mutagenesis, Impairment of Fertility Examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first ten days following the onset of menses. Pregnancy Category C It is not known whether Tl 201 Injection can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Tl 201 Injection should be given to a pregnant woman only if clearly needed.


Slide 22:Nursing Mothers This drug is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings. Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function. Tl 201 is excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Geriatric Use


Slide 23:ADVERSE REACTIONS Reactions that have been reported with the administration of Tl 201 include allergic-type skin reactions, itching, hypotension, nausea, sweating, and blurred vision. DOSAGE AND ADMINISTRATION Adult (70 kg) dose of Tl 201 is 37-74 MBq (1-2 mCi). Tl 201 is intended for intravenous administration only. Patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. For resting thallium studies, imaging should begin 10-20 minutes after injection. For the localization of parathyroid hyperactivity, Tl 201 may be administered before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc99m or sodium iodide I 123 to enable thyroid subtraction imaging.


Slide 24:RADIATION DOSIMETRY The estimated absorbed doses at calibration time to an average patient (70 kg) from an intravenous injection of a maximum dose of 74 MBq, 2 mCi of Thallous Chloride Tl 201 Injection. Tissue mGy/74 MBq Rads/2 mCi Heart Wall 10.0 1.0   Liver 12.0 1.2   Kidneys 24.0 2.4   Testes 11.0 1.1   Ovaries    9.6 0.96 Thyroid    9.6 0.96 Gastrointestinal Tract:   Stomach Wall    8.2 0.82   Small Intestine    7.8 0.78   Upper Large Intestine Wall    5.2 0.52   Lower Large Intestine Wall    4.4 0.44 Total Body    4.4 0.44


Slide 25:HOW SUPPLIED Tl 201 for intravenous administration is supplied as a sterile, nonpyrogenic solution containing at calibration time, 37 MBq/ml (1 mCi/ml) of Thallous Chloride Tl 201 Injection, 9 mg sodium chloride/ml and 0.009 ml of benzyl alcohol/ml. pH is adjusted with hydrochloric acid and/or sodium hydroxide solution. Vials are available in the following quantities of radioactivity: 244.2 and 325.6 MBq, 6.6 and 8.8 mCi of Thallous Chloride Tl 201 Injection.


Slide 26:STORAGE CONDITIONS Drug should be stored at controlled room temperature of 20-25°C (68-77°F). Storage and disposal of Tl 201 should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.


Slide 27:Radionuclide: Tl 201 T½ - 73hrs Energies – 68-80 keV k x-ray, 135, 167 keV Type- EC, γ, accelerator Radiopharmaceutical: Tl 201- thallous chloride Localization: Similar to potassium, distributes with NA/K pump within 20 mins of injection Then seeps out of myocardium and redistributes (tb= 10 days ± 2.5 days) Quality Control: Chromatography > 95% Use within 7 days Adult dosage: 2-5 mCi (74- 185 MBq) Cardiac- Rest Test Tl-201


Slide 28:Method of Administration: Thallium redistribution (3-4hr after injection No injection for redistribution needed unless it is a rest only study Some stress-redistribution protocols calls for 2nd injection (~1mCi IV) 15mins before imaging Separate day- IV Indications: Detection and Evaluation of coronary artery disease Evaluation for coronary bypass surgery or angioplasty Detection and evaluation for viable or hibernating myocardial tissue Evaluation of physical indicators: Myocardial infraction, chest pain, SOB, hx of heart disease Evaluation of laboratory indicators: Elevated levels of creatine phosphokinase Evaluation of the heart due to abnormal results on related studies


Slide 29:Contradictions: Patient should not be taking chemical stressors, e.g. caffeine, dipyridamole Patient should be NPO for 4-12 hrs Severe arrhythmia if a gated resting study is ordered Patient Preparation: Identify patient. Verify doctors order. Explain procedure Tell patient to be NPO for 4-12hrs Patient should be well rested and avoid strenuous exercise the day of test Remove 10 ECG leads and electrodes if necessary or use tree lead ECG if it is gated test Position patient sitting upright for 15 mins before injection to reduce pulmonary and splanchnic blood flow


Slide 30:Camera: Large field of View Collimator: Low energy, all purpose, or low energy, high resolution Computer Setup: Window at (minimum) Hg k x-rays (68-80 keV) and 167 keV at 20% Static: Timed for 300 seconds Single Photon Emission Tomography (SPECT): 180°, 32 or 64 projections 20 to 40 sec/frame, 8 frames/cycle if gated Matrix 64 x 64, runs~ 25 mins Equipment


Slide 31:Procedure Patient waits 5-20 mins after injection Position patient supine with heart in center of field of view and left arm up over the head Images may include a static anterior picture first (300 seconds) Start SPECT images at appropriate time with camera right anterior oblique to left posterior oblique Processing: Computer analysis of left ventricle showing the vertical long axis, horizontal long axis and short axis


Slide 32:Normal Results Heterogeneous uptake of the left ventricular myocardium Heterogeneous uptake of the right ventricular myocardium if processing was requested Abnormal Results Areas of little or no uptake exhibiting a cold spot Left ventricular walls of interest and their supplied arteries: Apical: left anterior descending, distal end, and right coronary artery, posterior descending Septal: Left anterior descending Anterior: Left anterior descending Lateral: Left circumflex Inferior: Right coronary artery


Slide 33:artifacts Patient is no NPO for 4 plus hours Articles in pockets, necklaces, heart monitors, pacemakers, or metal buttons If patients left arm is down to side, it can cause unwanted attenuation


Slide 34:Protocols Stress is done first, imaged as soon as possible, than imaged again 3-4 hrs later. Rest study is completed using its ability to redistribute. Some perform a 24hr delay rest study with a 1mCi reinjection , wait 5-20mins, looking for hibernating tissue. Thallium-Thallium: both test are done with thallium on different days. Thallium-Sestamibi (dual energy-dual isotope: Thallium rest study (3mCi) is done first (inject, wait ~20mins, image), followed by by the stress test using sestamibi


Slide 35:Patient History Do you have any history of or family history of heart disease? Do you have a history of heart attacks? Have you had any chest pain? If so, when and are you having chest pain now? Have you been sort of breath, had trouble breathing, or do you have asthma? Do you or did you smoke? When did you quit? Do you have a pacemaker? Have you had any recent surgery? Have you had any recent chemotherapy? Do you have high blood pressure of diabetes? Are you allergic to any medications? What medications are you presently taking? Have to had any prior ECG tests or related test (echocardiography, stress test, etc)? Do you have results of recent lab work? Females: Are you pregnant or nursing?


Summary :Summary Thallium 201 is used for myocardium perfusion rest test 2- 5 mCi is injected IV into the patient Patient should be NPO for 4-12 hrs Done at 180°, 64 projections, 20 - 40 sec/frame, Matrix 64 x 64 Patient waits 5-20 mins after injection Position patient supine with heart in center of field of view RAO-LPO projection Stress part of exam is usually done first


Questions :Questions What type of collimator is used? How long before the test does the pt have to be NPO? How is the radiopharmaceutical administered? What size matrix is used? TRUE/FALSE The cardiac study is done from RPO to LAO. How must Tl201 is administered? List some patient artifacts that can show up in the study? True/False Areas of little or no uptake exhibiting a cold spot are results of an abnormal study.


Answers :Answers Low energy, all purpose 4-12 hrs IV 64 x 64 False 2-5 mCi articles in pockets, necklaces, heart monitors, pacemakers, or metal buttons True