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135La As an Auger-Electron Emitter for Targeted Internal Radiotherapy 4 5 6 1 2,3 4 1 1 3 3 7 J

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135La As an Auger-Electron Emitter for Targeted Internal Radiotherapy 4 5 6 1 2,3 4 1 1 3 3 7 J Page 1 of 18 AUTHOR SUBMITTED MANUSCRIPT - PMB-106069.R1 1 2 3 135La as an Auger-electron emitter for targeted internal radiotherapy 4 5 6 1 2,3 4 1 1 3 3 7 J. Fonslet , B.Q. Lee , T.A. Tran , M. Siragusa , M. Jensen , T. Kibédi , A.E. Stuchbery , G.W. 8 Severin1,5,6* 9 10 1Hevesy Laboratory, Center for Nuclear Technologies, Technical University of Denmark, Roskilde, 11 12 Denmark 13 2Department of Oncology, Oxford University, Oxford, United Kingdom 14 15 3Department of Nuclear Physics, Australia National University, Canberra, Australia 16 4 17 Lund University Bioimaging Center, Lund University, Lund, Sweden 18 5Department of Chemistry, Michigan State University, East Lansing, MI, USA 19 20 6Facility for Rare Isotope Beams, Michigan State University, East Lansing, MI, USA 21 22 23 Abstract: 24 135 25 Introduction: La has favorable nuclear and chemical properties for Auger-based targeted internal 26 radiotherapy. Here we present detailed investigations of the production, emissions, and dosimetry related 27 28 to 135La therapy. 29 135 nat 30 Methods and Results: La was produced by 16.5 MeV proton irradiation of metallic Ba on a medical 31 cyclotron, and was isolated and purified by trap-and-release on weak cation-exchange resin. The average 32 33 production rate was 407 ± 19 MBq/µA (saturation activity), and the radionuclidic purity was 98% at 20 h 34 post irradiation. Chemical separation recovered > 98 % of the 135La with an effective molar activity of 70 35 36 20 GBq/µmol. To better assess cellular and organ dosimetry of this nuclide, we have calculated the X- 37 38 ray and Auger emission spectra using a Monte Carlo model accounting for effects of multiple vacancies 39 during the Auger cascade. The generated Auger spectrum was used to calculate cellular S-factors. 40 41 Conclusion: 135La was produced with high specific activity, reactivity, radionuclidic purity, and yield. 42 43 The emission spectrum and the dosimetry are favorable for internal radionuclide therapy. 44 Keywords: lanthanum-135, La-135, radiolanthanide, auger therapy, targeted radionuclide therapy, 45 46 radionuclide production 47 48 49 50 51 52 53 54 55 56 * 57 [email protected] – corresponding author 58 59 60 AUTHOR SUBMITTED MANUSCRIPT - PMB-106069.R1 Page 2 of 18 1 2 3 1 Introduction: 4 5 2 The development of targeted internal radiotherapy for cancer and patient specific treatment requires 6 7 3 radionuclides with suitable half-lives, chemical properties and emissions. Several nuclides are already in 8 4 clinical use, notably the beta emitters 177Lu and 90Y [1,2]. In addition, preclinical studies with other 9 10 5 lanthanides, especially the terbium isotopes 149, 151, 155, 161Tb show promise, providing a matched set of 11 isotopes with diagnostic positrons and therapeutic alpha- and beta-particles, as well as Auger electrons 12 6 13 7 [3–6]. The radioactive isotopes of lanthanum are chemically similar to the other lanthanides, and one in 14 135 15 8 particular, La has potential as a therapeutic Auger electron emitter. 16 9 17 18 10 Auger electron emitters are particularly interesting because they have the capability to deliver radiation 19 20 11 dose to individual targeted cells while sparing surrounding tissues. This is in contrast to more commonly- 21 12 used therapeutic nuclides, like 177Lu and 90Y, which have beta emissions that traverse many cell lengths, 22 23 13 with dispersed energy deposition. The very low energy and multiplicity of Auger electrons may prove 24 useful in targeted therapy, especially in the treatment of diffuse and disseminated disease, where other 25 14 26 15 nuclear emissions do not allow adequate dose to the targeted cell due to excessive particle range. Further, 27 28 16 there is mounting evidence that the relative biological effectiveness (RBE) of multiple low energy 29 17 electrons (<10 keV) significantly exceeds that of photons and higher energy beta particles [7]. In some 30 31 18 cases the biological effect of absorbed dose from Auger electrons is 2-10 times higher than X-rays of the 32 33 19 same energy, meaning that these emissions are more potent in introducing radiation damage to living cells 34 20 [8–10]. Therefore, coupling Auger emitting radionuclides like 135La with highly specific targeting vectors, 35 36 21 particularly cell-nucleus targeting moieties, has potential as a powerful therapeutic tool. 37 38 22 39 23 135La decays by electron capture (EC), primarily ( >98%) to the ground state of stable 135Ba, with a half- 40 41 24 life of 18.9 hour [11] (Figure 1). Following the decay Auger electrons are emitted which are potentially 42 25 useful for internal radiotherapy. Throughout this paper we use the term “Auger electrons” as designation 43 44 26 for all Auger cascade electrons, including the Coster-Kronig and Super-Coster-Kronig electrons. X-rays 45 46 27 accompany the Auger cascade with a spectrum sufficient for Single Photon Emission Computed 47 28 Tomography (SPECT) imaging capabilities. This allows for concurrent SPECT imaging in small animals, 48 49 29 facilitating dosimetry calculations in small animal models [12]. In the projected future human use of 50 51 30 therapeutic doses, the activity could be high enough to allow whole-body SPECT based on the 480.5 keV 52 31 gamma emissions. 53 54 55 56 57 58 59 60 Page 3 of 18 AUTHOR SUBMITTED MANUSCRIPT - PMB-106069.R1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 32 27 33 Figure 1 Simplified decay scheme of 135La[11,13]. 28 29 34 30 31 35 When considering employing 135La as a radiotherapeutic nuclide, it is necessary to make detailed dose 32 33 36 calculations. This is important not only on the organ level, but also on the cellular level, due to the highly 34 35 37 localized dose deposition from emitted Auger electrons. In order to get a realistic dose estimate the entire 36 38 emission spectrum needs to be well understood. The conventionally-used databases (like NuDat 2 [14]) 37 38 39 only give a condensed version of the Auger cascade emissions, without addressing the many electrons 39 40 40 below 3 keV. Lee et al. recently developed an Auger-cascade model, BrIccEmis, based on a Monte Carlo 41 41 technique for determining X-ray and Auger emission spectra [15,16]. For the present work, the model was 42 135 43 42 used to obtain detailed radiation spectra from La, especially for very low-energy Auger electrons and 44 43 X-rays. Prescher et al. [17], and Tárkányi et al. [18] determined the production cross-sections for 135La 45 46 44 during proton irradiation of natBa at energies ranging from 12-70 MeV. Evident in their data is the fact 47 135 48 45 that La is the primary radionuclide with half-life longer than a few minutes produced in the proton- 49 46 induced reactions on natural barium at energies available on most medical cyclotrons. 50 51 47 52 135 53 48 In this work, we detail the properties of La as a radiotherapeutic nuclide. The practical considerations 54 49 of production, purification, and radiolabeling are experimentally determined and optimized for the 55 56 50 chelator DTPA (diethyeneltriaminepentacetic acid). Additionally, reevaluations of the Auger and X-ray 57 58 59 60 AUTHOR SUBMITTED MANUSCRIPT - PMB-106069.R1 Page 4 of 18 1 2 3 51 emission spectra are presented along with a calculation of the cellular S-factors and a dosimetry 4 5 52 comparison to the commonly used radiotherapeutic isotopes 177Lu and 90Y. 6 7 53 8 54 Materials and Methods: 9 10 55 General 11 All reagents were obtained from Sigma Aldrich and used without further purification unless otherwise 12 56 13 57 noted. All water was 18 MΩ MilliQ-grade (Sartorious). Hydrochloric acid (HCl) solutions were diluted 14 15 58 from 37% aq. HCl (Fluka TraceSelect) with water. pH was determined by pH paper (PEHANON 1-12 16 59 and 4-9). Gamma spectroscopy was performed on a Princeton Gammatech LGC 5 germanium detector, 17 18 60 calibrated using certified 133Ba and 152Eu sources. 19 20 61 21 62 Cyclotron Production of 135La from natBa 22 23 63 Chunks of dendritically distilled metallic barium (99.99% trace metal grade) totaling 314-550 mg were 24 pressed with a hydraulic press (20 kN/cm2) into a 9 mm diameter x 3 mm deep divot in a 28 mm diameter 25 64 26 65 x 5 mm thick silver disc. The barium was immediately covered with either 100 µm aluminum or 25 µm 27 28 66 niobium foil to reduce the exposure to atmospheric oxygen, and placed into a target holder supplying 29 67 direct water cooling to the backside of the silver. A rough schematic of the target and target holder can be 30 31 68 seen in a paper by Severin et al. [19]. The target holder was mounted onto a PETtrace cyclotron (PT800 32 33 69 General Electric) and irradiated at 90° (normal) incidence with 16.5 MeV protons at 15 µA for 235-280 34 134 136 70 min. Owing to the co-production of short-lived La (t½ = 6.5 min) and La (t½ = 9.9 min), and slightly 35 132 133 36 71 longer-lived La (t½ = 4.5 h) and La (t½ = 3.9 h), the targets were allowed to decay for 12-24 hours 37 before further handling. 38 72 39 73 40 135 41 74 In order to determine the production rates of La and the other longer-lived co-produced radioisotopes 42 75 (132La, 133La and 135mBa), a single thick target of Ba totaling 472 mg was irradiated at 30 µA for 227 43 44 76 minutes.
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