EMU: Acquisition of equipment for the synthesis and quality control of radiopharmaceuticals labeled with carbon-11 for use in pre-clinical and clinical molecular imaging research.

• Grant number: 23/16944-0
• Support Opportunities: Research Infrastructure Program - Small Medium Sized
• Start date: September 01, 2024
• End date: August 31, 2027
• Field of knowledge: Health Sciences - Medicine - Medical Radiology
• Principal Investigator: Carlos Alberto Buchpiguel
• Grantee: Carlos Alberto Buchpiguel
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Daniele de Paula Faria ; Geraldo Busatto Filho

Abstract

Radiopharmaceuticals are medicines with diagnostic or therapeutic purposes that, when ready for use, contain one or more radionuclides. Radiopharmaceuticals with a short half-life (less than two hours) are produced in cyclotrons that can be present in public and private institutions since the break of the Brazilian government monopoly in 2008. This break in monopoly enabled the installation of the first cyclotron (particle accelerator for the production of radioisotopes) at a Brazilian university, which was at the University of São Paulo, at the Institute of Radiology (InRad), constituting the Integrated Center for Production of Radiopharmaceuticals of the Institute of Radiology - FMUSP-HC (CinRad). Next to the cyclotron installation, a pharmaceutical production area was set up for the production of radiopharmaceuticals for healthcare purposes.In 2014, with funding from the FAPESP project 2012/50329-6, under the responsibility of Prof. Dr. Geraldo Busatto Filho, equipment for the production of radiopharmaceuticals labeled with carbon-11 was purchased and installed. The first radiopharmaceutical produced and validated for use in animals and humans was 11C-PIB (Pittsburgh Compound B) used for beta-amyloid plaques detection to aid in the diagnosis of Alzheimer's Disease. The structure for the production of radiopharmaceuticals labeled with carbon-11 enabled the development of several research projects at FMUSP. This institution was the first in the country to produce 11C-PIB and was therefore the first to perform positron emission tomography (PET) imaging of beta-amyloid plaque (amyloid PET). This fact made it possible to place Brazilian studies on Dementia and Alzheimer's Disease on the world stage. We are producing carbon-11 at FMUSP for 10 years, which is an achievement in our history, however this time of use has already caused some equipment to deteriorate and need to be replaced and these are the equipment that are being requested in this call, essential equipment for maintain the production of radiopharmaceuticals labeled with carbon-11 in our institution, to continue serving different research projects in the state of São Paulo, and even beyond, and also maintain the medical activity of PET-amyloid imaging, which has become even more important with the recent advent of anti-amyloid therapy.The researcher responsible for this proposal, Prof. Dr. Carlos Alberto Buchpiguel is the coordinator of two multi-user cores, both belonging to the Multi-User Equipment Program (PREMiUM Network) of the Faculty of Medicine of the University of São Paulo (FMUSP). Both cores are located in the building of the Nuclear Medicine Center of the HC-FMUSP Institute of Radiology: "PET for small animals" since 2015 and the "Radioisotope Production" center since 2023.In this proposal, a total of 4 pieces of equipment are being requested, with the purpose of production and quality control of radiopharmaceuticals labeled with the carbon-11 radioisotope: 1) MilliQ water purifier: equipment for purifying water used in the preparation and analysis of laboratory samples with "Good manufacturing practices" qualification; 2) Carbon-11 synthesis module: automated equipment for labeling and purifying molecules with carbon-11; 3) Gas chromatograph: equipment designed to control residual solvents from radiopharmaceuticals; 4) Dose calibrator: equipment intended for measuring radioactive activity and quality control of radionuclide identity.The approval of the requested equipment will promote the continuity and expansion of our contribution in the area of pre-clinical and clinical molecular imaging, serving our research projects and those of several other centers, in addition to continuing to offer this service in an assistive manner in the largest hospital of Latin America. (AU)