Influence of Storage Temperature on Radiochemical Purity of 99mTc-Radiopharmaceuticals

The influence of effective room temperature on the radiochemical purity of 99mTc-radiopharmaceuticals was reported. This study was born from the observation that in the isolators used for the preparation of the 99mTc-radiopharmaceuticals the temperatures can be higher than those reported in the commercial illustrative leaflets of the kits. This is due, in particular, to the small size of the work area, the presence of instruments for heating, the continuous activation of air filtration, in addition to the fact that the environment of the isolator used for the 99mTc-radiopharmaceuticals preparation and storage is completely isolated and not conditioned. A total of 244 99mTc-radiopharmaceutical preparations (seven different types) have been tested and the radiochemical purity was checked at the end of preparation and until the expiry time. Moreover, we found that the mean temperature into the isolator was significantly higher than 25 C, the temperature, in general, required for the preparation and storage of 99mTc-radiopharmaceuticals. Results confirmed the radiochemical stability of radiopharmaceutical products. However, as required in the field of quality assurance, the impact that different conditions than those required by the manufacturer on the radiopharmaceuticals quality have to be verified before human administration

Applying Data Warehousing to a Phase III Clinical Trial From the Fondazione Italiana Linfomi Ensures Superior Data Quality and Improved Assessment of Clinical Outcomes

Data collection in clinical trials is becoming complex, with a huge number of variables that need to be recorded, verified, and analyzed to effectively measure clinical outcomes. In this study, we used data warehouse (DW) concepts to achieve this goal. A DW was developed to accommodate data from a large clinical trial, including all the characteristics collected. We present the results related to baseline variables with the following objectives: developing a data quality (DQ) control strategy and improving outcome analysis according to the clinical trial primary end points

An Approach Based on Process Modeling for Implementing a Health Information Technology in Clinical Practice

The introduction of a new Health Information Technology (HIT) in a healthcare context is a very complex process. The aim of this study is to propose a completely original approach for the implementation a new HIT in a healthcare facility or department. This novel approach is made of four steps and based on process modeling. The first step is the identification of all the stakeholders involved. The second step consists in performing a detailed description of all clinical and administrative processes that will use the new HIT in order to understand how people, resources and documents interact among them. The third step allows the analysis of the HIT functionalities in order to highlight potential problems or risks that could emerge during its daily usage and guarantee its interoperability with other software. The fourth step concerns the construction of an adoption plan, in order to avoiding sharp transitions. A set of tools were associated to each step to guarantee a correct design and implementation. An application concerning the implementation of a new commercial HIT for Computerized Provider Order Entry (CPOE) in the oncology department of a large Italian hospital is reported as an example of the proposed approach. Furthermore, the user satisfaction about the introduction of the new CPOE in the oncology department was evaluated by means of a set of questionnaires. A positive evaluation of the process emerged from this analysis, confirming the goodness of the proposed approach. Moreover, the questionnaires results showed a high level of user satisfaction

Data quality improvement of a multicenter clinical trial dataset

Medical datasets are usually affected by several problems, such as missing values, inconsistencies, redundancies, that can influence the data mining process and the extraction of useful knowledge. For these reasons, a preprocessing phase should be performed for improving the overall quality of data and, consequently, of the information that may be discovered from them. In this study we applied five steps of data preprocessing to improve the quality of a large dataset derived from a multicenter clinical trial. Our dataset included 298 patients enrolled in a prospective, multicenter, clinical trial, characterized by 22 input variables and one class variable (MIPI value). In particular, data coming from different medical centers were firstly integrated to obtain a homogeneous dataset. The latter was normalized to scale all variables into smaller and similar intervals. Then, all missing values were estimated by means of an imputation step. The complete dataset was finally discretized and reduced to remove redundant variables and decrease the amount of data to be managed. The improvement of data quality after each step was evaluated by means of the patients' classification accuracy using the KNN classifier. Our results showed that the proposed pipeline produced an increment of more than 20% of the classification performances. Moreover, the highest growth of accuracy was obtained after missing value imputation, whereas the discretization and feature selection steps allowed for a significant reduction of variables to be managed, without any deterioration of the information contained in data

Automated synthesis of 68Ga-DOTA-TOC with a cationic purification system: Evaluation of methodological and technical aspects in routine preparations

Background and Objective: Gallium-68 is a PET isotope available in each nuclear medicine departments, even those not equipped with a cyclotron, since it is easily obtained by eluting compact and transportable generator system. The preparation of Ga-68 DOTA-labeled compounds is performed by remotely controlled automated systems developed in order to ensure production efficiency, reproducibility of the results, fast reaction time, to facilitate the synthesis and minimize the radiation exposure. Many automatic synthesis systems are available on the radiopharmaceutical market, however, they Y requires some technical adaptations for routine use. We reported the [68Ga]Ga-DOTA-TOC production by automated cassette-based theranostic synthesizer system used in combination with a disposable GMP grade cassette system for cationic purification. Methods: The synthesizer is integrated with the68Ge/68Ga generator systems and it allows to perform elution, eluate purification and radiolabeling in about 38 minutes. We have performed in 2 year (January 2016-January 2018) over 100 [68Ga]Ga-DOTA-TOC preparations. Results: The average synthesis yield of radiopharmaceutical production was 54.4 ± 2.3 % and the radiochemical purity average was found 96.94 ± 0.74 %. Only three [68Ga]Ga-DOTA-TOC preparations have failed. Conclusion: The methodology and the adopted technical solutions allowed to obtain a high quality radiopharmaceutical product as required by the European Pharmacopoeia

Influence of Storage Temperature on Radiochemical Purity of 99mTc-Radiopharmaceuticals

The influence of effective room temperature on the radiochemical purity of 99mTc-radiopharmaceuticals was reported. This study was born from the observation that in the isolators used for the preparation of the 99mTc-radiopharmaceuticals the temperatures can be higher than those reported in the commercial illustrative leaflets of the kits. This is due, in particular, to the small size of the work area, the presence of instruments for heating, the continuous activation of air filtration, in addition to the fact that the environment of the isolator used for the 99mTc-radiopharmaceuticals preparation and storage is completely isolated and not conditioned. A total of 244 99mTc-radiopharmaceutical preparations (seven different types) have been tested and the radiochemical purity was checked at the end of preparation and until the expiry time. Moreover, we found that the mean temperature into the isolator was significantly higher than 25 °C, the temperature, in general, required for the preparation and storage of 99mTc-radiopharmaceuticals. Results confirmed the radiochemical stability of radiopharmaceutical products. However, as required in the field of quality assurance, the impact that different conditions than those required by the manufacturer on the radiopharmaceuticals quality have to be verified before human administration