Mon, 30 Sep 2024 in Brazilian Journal of Radiation Sciences
The Historical Background of Quality Assurance at Laboratório de Imagem Molecular of the Centro de Desenvolvimento da Tecnologia Nuclear
Abstract
The Centro de Desenvolvimento da Tecnologia Nuclear has a small animals positron emission tomograph in its Laboratório de Imagem Molecular. This equipment, the GE HealthCare LabPET SOLO 4 model, is widely used in preclinical studies related to the development of new radiopharmaceuticals or novel applications of conventional radiopharmaceuticals. The “PET Image Quality” subproject, integrated into the Centro de Desenvolvimento da Tecnologia Nuclear multi-year planning for 2018-2022, proposed actions involving quality assurance and human resources development for the laboratory. This work aims to consolidate the historical trajectory of Quality Assurance at Laboratório de Imagem Molecular of the Centro de Desenvolvimento da Tecnologia Nuclear. A search for documents related to the laboratory was conducted in the institutional quality system, called d-Qualidade, while a search for the curricula vitae of laboratory researchers was performed on the Plataforma Lattes, with the purpose of identifying the main products generated related to the Quality theme in the laboratory. The scientific production of the laboratory team demonstrates its pioneering role in Brazil in developing studies about the Quality Management applied to the small animals positron emission tomogragh. The laboratory history in the field of Quality Management emphasizes its national prominence and reveals the group's commitment over the past decade to significant technical/scientific production.
Main Text
1. INTRODUCTION
The Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN) has a small animal PET (Positron Emission Tomography) scanner in its Laboratório de Imagem Molecular (LIM/CDTN). This PET scanner, model LabPET SOLO 4 GE HealthCare, is used routinely in preclinical studies related to the development of new radiopharmaceuticals or new applications of traditional radiopharmaceuticals [1]. The origin of LIM/CDTN is directly linked to the Instituto Nacional de Ciência e Tecnologia de Medicina Molecular (INCT-MM).
INCT-MM was established from the call for proposals nº15/2008 launched by the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) with the aim of supporting scientific, technological and innovation research activities in Brazil. This public call selected and financed projects to forming or to consolidating the Institutos Nacionais de Ciência e Tecnologia (INCT). In this contexto, the objective of the INCT-MM was to integrate basic and technological science into clinical practice, focusing on investigating the molecular and cellular bases of serious diseases [2, 3, 4].
INCT-MM was idealized by scientists from three different Brazilian states: Minas Gerais, Rio Grande do Sul and Santa Catarina. The institutions involved were: (i) in Minas Gerais: Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN), Fundação Nacional Ezequiel Dias (FUNED), Hospital Júlia Kubitschek, Pontífica Universidade Católica de Minas Gerais (PUC-MG), Universidade Federal de Minas Gerais (UFMG), Universidade Federal de Ouro Preto (UFOP); (ii) in Rio Grande do Sul : Universidade Federal de Santa Maria (UFSM); (iii) in Santa Catarina : Universidade do Extremo-sul Catarinense (UNESC). The INCT-MM host institution was the Faculdade de Medicina da UFMG and the institute was coordinated by the UFMG Full Professor Dr. Marco Aurélio Romano-Silva [3].
Through INCT-MM, a human PET scanner was acquired in 2011, giving rise to the Centro de Imagem Molecular (CIMOL), which later became the Centro de Tecnologia em Imagem Molecular (CTMM) at UFMG [5]. Additionally, a small animals PET scanner was acquired, giving rise to the Laboratório de Imagem Molecular (LIM) at CDTN. Since then, the LIM/CDTN operates regularly the PET scanner. Figures 1 and 2 presents the LIM/CDTN.
In 2018, the CDTN/CNEN multi-year planning, PPA-2018 to 2022, included the subproject named PET Image Quality, which brought together all the actions of LIM/CDTN researchers related to Quality Assurance. Research and development actions, human resources training and also implementation of the internal quality management system were included in the subproject – which was a part of the Project 0861.01 Development and Applications of PET Radiopharmaceuticals.
The objective of this work is to investigate and consolidate the historical trajectory of Quality Assurnce at LIM/CDTN.
2. MATERIALS AND METHODS
A document search related to LIM/CDTN was carried out in the CDTN d-Qualidade internal system – a system whose objective is to manage the CDTN's quality documentation. In this system, all internal normative documentation can be consulted, such as Institutional Plans and Programs, Quality Manuals, Internal System Procedures, Internal Operational Procedures, and others. Additionally, a search for the curricula vitae of LIM/CDTN researchers was carried out on the Plataforma Lattes [7], with the purpose of identifying the main products related to the Quality subject in LIM/CDTN, such as national and international scientific papers, publications of papers in congress proceedings and personnel training.
3. RESULTS AND DISCUSSION
Tables 1 to 6, presents the main LIM/CDTN products, obtained at CDTN d-Qualidade system and in the Plataforma Lattes. It is important to note that the Table does not present the entire LIM/CDTN production. Products such as participation in events, abstracts and expanded abstracts, lectures, guest lectures and others are not listed.
The scientific production of LIM/CDTN reveals its pioneering activity in Brazil in the development of works related to Quality Management. A doctoral thesis (2016 to 2019) developed at LIM/CDTN proposed a Preclinical Image Quality Assurance Program as a standardization to be adopted in Brazil [1].
Currently, there are 6 preclinical PET imaging centers in Brazil [22]. Among these, LIM/CDTN is the only one with the Preclinical Image Quality Assurance Program implemented. Comparative studies for the performance of small animal PET scanners at LIM/CDTN and two other centers were carried out in partnership with other laboratories [19], revealing the feasibility of a National Preclinical Image Quality Assurance Program, as proposed [1, 17]. It is important to note that there is no specific national legislation for research laboratories focusing on Quality Assurance of preclinical PET imaging [17].
4. CONCLUSIONS
The analysis of LIM/CDTN products in recent years (2018 to 2023) revealed its team's commitment to quality management, highlighting (i) its regular scientific production, (ii) the implementation of laboratory operational procedures, (iii) the training of undergraduate and postgraduate students. The analysis additionally revealed that in the Brazilian scenario, LIM/CDTN stands out for its proposal for a National Preclinical Image Quality Assurance Program.
Abstract
Main Text
1. INTRODUCTION
2. MATERIALS AND METHODS
3. RESULTS AND DISCUSSION
4. CONCLUSIONS