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On the 1St Research Coordination Meeting On REPORT on the 1st Research Coordination Meeting on “Development of Therapeutic177 Radiopharmaceuticals Based on Lu for Radionuclide Therapy” 4 to 8 December 2006 IAEA Headquarters Vienna, Austria 2 Participants of the Research Coordination Meeting on “Development of Therapeutic Radiopharmaceuticals Based on 177Lu for Radionuclide Therapy” 4 to 8 December 2006 IAEA Headquarters in Vienna, Austria 3 4 CONTENTS 1. Introduction................................................................................................................... 5 2. Overall Objective:......................................................................................................... 7 3. Specific Research Objective: ........................................................................................ 7 4. Expected Research Outputs (Results):.......................................................................... 7 5. Summary of Country Presentation................................................................................ 8 6. Formulation of the Work plan of the CRP.................................................................. 19 7. Cooperation among participants ................................................................................. 33 8. Recommendations....................................................................................................... 33 9. Conclusion .................................................................................................................. 34 Country Reports .............................................................................................................. 36 Argentina...................................................................................................................................... 37 Austria.............................................................................................................................................41 Brazil...............................................................................................................................................48 Chile................................................................................................................................................61 China...............................................................................................................................................68 Cuba................................................................................................................................................79 Czech Republic...............................................................................................................................86 Hungary..........................................................................................................................................95 India................................................................................................................................................97 Italy...............................................................................................................................................116 Pakistan.........................................................................................................................................122 Peru...............................................................................................................................................134 Poland...........................................................................................................................................141 Russian Federation........................................................................................................................152 Uruguay.........................................................................................................................................163 USA...............................................................................................................................................171 Agenda .........................................................................................................................................175 List of Participants ....................................................................................................................178 5 1. Introduction - Radionuclide therapy (RNT) employing radiopharmaceuticals labelled with β emitting radionuclides is fast emerging as an important part of nuclear medicine. Radionuclide therapy is effectively utilized for bone pain palliation, thus providing significant improvement in quality of life of patients suffering from pain resulting from bone metastasis. Targeting primary diseases by using specific carrier molecules labelled with radionuclides is also widely investigated and efficacious products have been emerging for the treatment of Lymphoma and Neuroendocrine tumours. In order to ensure the wider use of radiopharmaceuticals, it is essential to carefully consider the choice of radionuclides that together with the carrier molecules will give suitable pharmacokinetic properties and therapeutic efficacy. The criteria for the selection of a radionuclide for radiotherapy are suitable decay characteristics and amenable chemistry. However, the practical considerations in selecting a radionuclide for targeted therapy are availability in high radionuclidic purity as well as high specific activity and low production cost and comfortable delivery logistics. 177 Lu is one of the isotopes emerging as a clear choice for therapy. Worldwide, the isotope is under investigation for approximately 30 different clinical applications, including treatment of colon cancer, metastatic bone cancer, non-Hodgkin’s lymphoma, and lung cancer. 177 - Lu decays with a half-life of 6.71 d by emission of β particles with E max of 497 keV (78.6%), 384 keV (9.1%) and 176 keV (12.2%). It also emits γ photons of 113 keV (6.4%) and 208 keV (11%), that are ideally suited for imaging the in-vivo localization and dosimetric calculations applying a gamma camera. The physical half-life of 177 Lu is comparable to that of 131 I, the most widely used therapeutic radionuclide. The long half- life of 177 Lu provides logistic advantage for production, QA/QC of the products as well as feasibility to supply the products to places far away from the production site. Patients suffering from breast, lung and prostate cancer develop metastasis in bone in the advanced stage of their diseases and therapeutic radiopharmaceuticals such as 153 89 Sm-EDTMP and SrCl 2 are used effectively for pain palliation due to skeletal metastases. Despite the fact that the above bone pain palliating agents give good clinical results; their wider use has met with practical difficulties. Though 153 Sm can be prepared in adequate quantities in medium flux reactors, its short half life (47 h) is the major disadvantage. It is essential to handle large quantities of activity to compensate for decay losses, during production and delivery of the radiopharmaceutical. In the case of 89 Sr, there is very limited capacity for production due to the very low cross section making this product expensive and unaffordable for many patients. It is expected that a 177 Lu based bone palliating agent will offer the same clinical efficacy without the disadvantages mentioned above. Currently there is good published data available on the production of 177 Lu and the preparation of phosphonates based radiopharmaceuticals which show high bone uptake. 177 Lu produced in the low to medium flux research reactors available in the MS can be used for bone pain palliation. High specific activity 177 Lu that is prepared in high flux research reactors is needed for radiolabelling antibodies and peptides. These antibodies introduced to patients alone or in conjunction with 90 Y products are showing promising 6 results in clinical trials. Large quantities of high specific activity 177 Lu can be prepared by irradiating enriched targets in high flux research reactors and hence, in the long term the cost of high specific activity 177 Lu should come down to reasonable levels. The wider availability of 177 Lu will make it feasible for the production of therapeutic radiopharmaceuticals with lower cost ensuring higher availability in MS. The CRP “Development of Therapeutic Radiopharmaceuticals Based on 177 Lu for Radionuclide Therapy”aims at developing therapeutic radiopharmaceuticals for bone pain palliation and targeted therapy of cancer. 2. Overall Objective: The overall objective of the CRP is to generate know how and expertise in participating laboratories for the production and radiochemical processing of 177 Lu and the preparation of therapeutic radiopharmaceuticals with it. 3. Specific Research Objective: The specific objectives of the CRP are outlined below: 177 • Development of technology for the production of Lu in the research reactors and its radiochemical processing. • Development of technologies for the production and QA/QC of bone pain palliating agents using 177 Lu and phosphonate ligands 177 • Development of a cold kit formulation of EDTMP for radiolabelling with Lu for achieving harmonized protocol for the clinical use of a 177 Lu-EDTMP as bone pain palliating agent • Develop appropriate protocols for QA/QC studies and biological evaluation of the radiopharmaceutical 177 • Development of Lu based primary cancer specific radiopharmaceuticals using carrier molecules such as antibodies (antibodies against EGF, PSA, Tenascin and Lymphoma cells) Peptides (Somatostatin
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