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Thallium-201 for Medical Use. I THALLIUM-201 FOR MEDICAL USE. I E. Lebowitz, M. W. Greene, R. Fairchild, P. R. Bradley-Moore, H. 1. Atkins,A. N. Ansari, P. Richards,and E. Belgrave Brookhaven National Laboratory Thallium-201 merits evaluation for myocar tumors (7—9), the use of radiothallium should also dial visualization, kidney studies, and tumor be evaluated for this application. diagnosis because of its physical and biologic Thallium-201 decays by electron capture with a properties. A method is described for prepara 73-hr half-life. It emits mercury K-x-rays of 69—83 tion of this radiopharmaceutical for human use. keY in 98% abundance plus gamma rays of I 35 and A critical evaluation of 501T1 and other radio 167 keV in 10% total abundance. Because of its pharmaceuticals for myocardial visualization is good shelf-life, photon energies, and mode of decay, given. 201T1was the radioisotope of thallium chosen for development. Thallium-20 1 is a potentially useful radioisotope MATERIALS AND METHODS for various medical applications including myocardial Thallium-201 is produced by irradiating a natural visualization and possible assessment of physiology, thallium target in the external beam of the 60-in. as a renal medullary imaging agent, and for tumor Brookhaven cyclotron with 3 1-MeV protons. The detection. nuclear reaction is 203Tl(p,3n)201Pb. Lead-201 has The use of radiothallium in nuclear medicine was a half-life of 9.4 hr and is the parent of 201T1.The first suggested by Kawana, et al (1 ) . In terms of thallium target, fabricated from an ingot of 99.999% organ distribution (2) and neurophysiologic function pure natural thallium metal (29.5% isotopic abun (3), thallium is biologically similar to potassium. dance of 203Tl), is I .3 cm in diameter and weighs The physical—chemicalexplanation for the biologic 0.7 gm. The target thickness and incident proton similarity of @+and K@ is that the hydrated ionic beam energy are chosen to minimize the production radius of 11+ is between K+ and Rb+ in size and of other radioisotopes of lead, which could lead to this radius has been suggested as the property that impurities in the 2011'lproduct. After irradiation, the determines passive penetration through a mem thallium target is dissolved in concentrated nitric brane (4). acid, then evaporated to dryness. This salt is then These facts suggest that radiothallium should be dissolved in 50 ml of 0.025 M EDTA at pH 4 and a good potassium analog and therefore has potential passed through a Bio-Rad Dowex 50 X 8 resin col for myocardial visualization and the early detection umn (Nat form, 50—[email protected] X 6 cm) . Most of areas of diminished perfusion and radionuclide of the thallium target material adheres to the column uptake as “coldspots―(regions of decreased ac and the eluate contains radioactive 203Pband 201Pb. tivity). The eluate is acidified by adding an equal volume of Presently used renal agents concentrate in the conc. HNO@and the thallium is oxidized by the addi cortex; unlike these, thallium preferentially concen tion of “Clorox.―Forty micrograms of Pb(N03)2 trates in the renal medulla (5) . This property may carrier are added to the eluate and the solution is be clinically useful. passed through a Bio-Rad Dowex 1 X 8 resin col The Tl@ is taken up more by tissues in pigmented umn (H@ f@yrm,50—100mesh, 2.5 X 6 cm). Thal than in albino rabbits, suggesting the use of radio thallium for the diagnosis of melanoma (6) . Because Received June 10, 1974; revision accepted Sept. 23, 1974. of the similarity of thallium to alkali metals such as For reprints contact: Elliot Lebowitz, Bldg. 801, Brook cesium, which has been shown to concentrate in haven National Laboratory, Upton, N.Y. 11973. Volume 16, Number 2 151 LEBOWITZ, GREENE, FAIRCHILD, BRADLEY-MOORE, ATKINS, ANSARI, RICHARDS, AND BELGRAVE hum adheres to this column and the lead activities are eluted. TABLE1. CHEMICALANALYSIS This eluate containing 203Pband 201Pbis allowed PRODUCTOFQuantityQuantityElement(/Lg)Element(‘ug)TI<2Ni<2Ca60Al1B<2Mo0.2Mg1Cu6Mn<0.2Ag<0.2Si0.2Ti1Fe1V1THE 201Tl to stand overnight to permit the 201Pbto decay into 201Tl It is then passed through another Bio-Rad Dowex 1 X 8 column to which the 2olTl+3 adheres and through which the lead activities are eluted. The 201'fl activity is then eluted with 20 ml of hot hy drazine-sulfate solution (20% w/v) , reducing Tl@ to Tl+l This TI +1 eluate is evaporated to dryness twice with conc. HNO:4 and once with conc. HC1. The product is then dissolved in 5 ml of 10_i M NaOH and the pH is adjusted to 7 by further addi tion of NaOH. The product is sterilized by ifitration by paper chromatography to differentiate Tl@1 and into a sterile multiinjection bottle through a 0.22- [email protected] No. 3 MM paper and a solvent 1/10 micron sterilized Millipore filter. (Na2HPO., -5H20) and 9/ 10 (acetone) are used. A Rhodamine B spot test is used to detect carrier The 11+1 stays at the origin. To demonstrate that thallium in the product before injection. The test the 20111is not in particulate form, the product is can detect 0.02 @gof thallium. The sample tested passed through a 250 A filter. is typically 1% of the total product; thus a negative Radionuclidic purity is analyzed by multichannel spot test insures that less than 2 @gof thallium is pulse-height analysis, utilizing a Ge(Li) detector. present in the product. A few weeks after the 20111 The gamma spectrum of the product is also followed is produced, a complete chemical analysis of the for approximately 1 week to confirm the half-lives of product is performed by emission spectroscopy. the product and impurity gamma rays. The radiochemical purity of the product is checked Product batches are tested for pyrogenicity by an 8 MED RUN P12 SE000S § 8 8 8 U, z LIR a a so' 8 @ 135 isV 1______ 8 2 / @ 54.00 1ie4X@ [email protected] 25S.@ @O.OO @4.OO [email protected] 532.00 640.00 7OS.@ ‘N.m eà .m [email protected], %O.OO CHANNEL NUFIOER FIG. 1. Ge(ti)spectrumof‘@TIproduct. 152 JOURNAL OF NUCLEAR MEDICINE 201T1FORMEDICALUSE. independent laboratory. All glassware is rendered 1000 r I I I apyrogenic by autoclaving at 180°Cfor 3 hr. Measurements of the excitation function (the pro duction cross section as a function of energy) are performed by irradiating a stack of thin (approxi 500 mately 0.2 gm/cm2) foils of thallium and analyzing the activities produced with a Ge(Li) detector. Lead -a 201 is determined by analysis of its 331-keV photon, E which is present in 82% abundance. b RESULTS Emission spectroscopic chemical analysis of an entire product batch is shown in Table 1. Figure 1 shows the Ge(Li) spectrum of the product, the main 00 peaks being the x-rays and photons of 20111.The 10 20 30 40 radioisotopic purity is @99%, as is shown in Table E ( MeV) 2. The product is at neutral pH, isotonic, sterile, and pyrogen-free. FIG.2.‘°‘TI(p,3n)'°@Pbexcitationfunction. The excitation function for the production of 201Pb,the parent of 20111,is seen in Fig. 2. By choos ing an energy range near the peak of the excitation the heart. Although the radioisotopes of potassium function, the production of 200Pb and 202Pb (the and cesium can both be used for myocardial visual parents of 200'fl and 202Tl) radiocontaminants is ization, their differences in biologic behavior are re minimized. With a natural thallium target, the pro flected in their clinical usefulness. duction rate of 20111is 0.7 mCi/@AH or correspond Advantages of potassium over cesium. First, be ingly higher with an enriched 20311target. The mi cause of its more efficient myocardial uptake and tial development work is being done on the Brook lack of recirculation, K+ is superior for quantitative haven 60-in. cyclotron but it should be possible to studies following intracoronary arterial injection evaluate the production capability of 20111 in the (10) . Second, because of its rapid blood clearance BLIP (Brookhaven Linac Isotope Producer) using and myocardial extraction, K+ can be used in the the 205Tl(p,5n)201Pb reaction. assessment of patients with transient myocardial is chemia (e.g., angina pectoris) by visualizing the myo DISCUSSION cardium before and after stress (11,12). Using the myocardial uptake of the analogs of Disadvantage of potassium. The rapid leakage of potassium, there are several alternatives for myo potassium from the myocardium constitutes a dis cardial visualization including the radioisotopes of advantage due to the inability to visualize the myo potassium, cesium, thallium, rubidium, and I3NH,+. cardium with potassium after the first hour post We start by comparing the biologic behavior of K@ injection (1 1 ), compared with the ability to use and Cs@ (10) . Potassium is more rapidly cleared cesium for this purpose for several hours (10,13). from the blood and extracted by the myocardium Since Tl+ is a good biologic analog of potassium, than is cesium. Potassium is extracted by the myo it should have the biologic advantages of K@ listed cardium with 71% efficiency on a single circulation earlier. Furthermore, Harper has observed that the compared with 22% efficiency for cesium. Following thallium activity remained in the myocardium even its extraction, potassium is cleared more rapidly from 18 hr postinjection in the one patient they scanned TABLE 2. RADIOISOTOPIC ANALYSIS OF 201Tl PRODUCT At time of preparation 18 hr later Isotope tim (%) (S/s) 73 hr later 146 hr later ‘°@Pb 52 hr 1.6 X 10' 1.5 X 102 1.2 X i0' 9.0 X 10' “TI 26 hr 1.3 X 10' 9.0 X 102 3j X 10@ 1.1 X 10' ‘@Tl 12.2 days 1.2 X 10' 1.4 X 101 2.0 X 10T' 3.4 X 101 Volume 16,Number 2 153 LEBOWITZ, GREENE, FAIRCHILD, BRADLEY-MOORE, A1KINS, ANSARI, RICHARDS, AND BELGRAVE Rubidium is a good analog of potassium (15) TABLE 3.
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