Abstract: HPLC-based quality control systems to perform quality control testing on a radiopharmaceutical solution shortly after synthesis. An HPLC-based quality control system makes efficient use of sample volume and is compatible with a variety of radioisotopes and radiopharmaceutical compounds. In several embodiments, the automated nature of an HPLC-based quality control system allows for quality control tests to be conducted quickly and with minimal impact on user workflow. When used as part of an integrated PET biomarker radiopharmaceutical production system, the present general inventive concept permits a manufacturer to produce product and conduct quality control tests with lower per dose costs.

Abstract: An automated radiopharmaceutical production and quality control system includes a particle accelerator, a radiopharmaceutical micro-synthesis subsystem, and quality control subsystem. The micro-accelerator of the improved biomarker generator is optimized for producing radioisotopes useful in synthesizing radiopharmaceuticals in quantities on the order of multiple unit doses, allowing for significant reductions in size, power requirements, and weight when compared to conventional radiopharmaceutical cyclotrons. The radiopharmaceutical micro-synthesis subsystem encompasses a small volume chemical synthesis system comprising a microreactor and/or a microfluidic chip and optimized for synthesizing the radiopharmaceutical in small quantities, allowing for significant reductions in processing time and in the quantity of radioisotope required. The automated quality control subsystem is used to test the composition and characteristics of the radiopharmaceutical to ensure that it is safe to inject.

Abstract: Microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, ten (10) unit doses of radiopharmaceutical biomarker for use in positron emission tomography (PET). A radioisotope from an accelerator or other radioisotope generator is introduced into a reaction vessel, along with organic and aqueous reagents, and the mixture heated to synthesize a solution of a pre-selected radiopharmaceutical. The solution is purified by passing through a combination of solid phase extraction purification components, trap and release components, and a filter. The synthesis process reduces waste and allows for production of biomarker radiopharmaceuticals on site and close to the location where the unit dose will be administered to the patient.

Abstract: An automated radiopharmaceutical production and quality control system includes a particle accelerator, a radiopharmaceutical micro-synthesis subsystem, and quality control subsystem. The micro-accelerator of the improved biomarker generator is optimized for producing radioisotopes useful in synthesizing radiopharmaceuticals in quantities on the order of multiple unit doses, allowing for significant reductions in size, power requirements, and weight when compared to conventional radiopharmaceutical cyclotrons. The radiopharmaceutical micro-synthesis subsystem encompasses a small volume chemical synthesis system comprising a microreactor and/or a microfluidic chip and optimized for synthesizing the radiopharmaceutical in small quantities, allowing for significant reductions in processing time and in the quantity of radioisotope required. The automated quality control subsystem is used to test the composition and characteristics of the radiopharmaceutical to ensure that it is safe to inject.

Abstract: An automated HPLC-based quality control system to perform quality control testing on a radiopharmaceutical solution shortly after synthesis. An automated HPLC-based quality control system makes efficient use of sample volume and is compatible with a variety of radioisotopes and radiopharmaceutical compounds. In several embodiments, the automated nature of an automated HPLC-based quality control system allows for quality control tests to be conducted quickly and with minimal impact on user workflow. When used as part of an integrated PET biomarker radiopharmaceutical production system, the present general inventive concept permits a manufacturer to produce product and conduct quality control tests with lower per dose costs and shorter testing times.

Abstract: Microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, ten (10) unit doses of radiopharmaceutical biomarker for use in positron emission tomography (PET). A radioisotope from an accelerator or other radioisotope generator is introduced into a reaction vessel, along with organic and aqueous reagents, and the mixture heated to synthesize a solution of a pre-selected radiopharmaceutical. The solution is purified by passing through a combination of solid phase extraction purification components, trap and release components, and a filter. The synthesis process reduces waste and allows for production of biomarker radiopharmaceuticals on site and close to the location where the unit dose will be administered to the patient.

Abstract: HPLC-based quality control systems to perform quality control testing on a radiopharmaceutical solution shortly after synthesis. An HPLC-based quality control system makes efficient use of sample volume and is compatible with a variety of radioisotopes and radiopharmaceutical compounds. In several embodiments, the automated nature of an HPLC-based quality control system allows for quality control tests to be conducted quickly and with minimal impact on user workflow. When used as part of an integrated PET biomarker radiopharmaceutical production system, the present general inventive concept permits a manufacturer to produce product and conduct quality control tests with lower per dose costs.

Abstract: A method for processing events in a medical imaging device may comprise the steps of receiving analog signals from at least one PMT into an Applied Specific Integrated Circuit (ASIC) comprising a Constant Fraction Discriminator (CFD) and transmitting analog outputs from the ASIC. Further, sampling the analog outputs continuously using an Analog to Digital Converter (ADC) and transmitting digital outputs; and collecting a number of samples of the digital output during a sampling period using a Field Programmable Gate Array (FPGA) when triggered by the CFD. The method may additionally determine the energy of the analog signals from the at lease one PMT by subtracting the peak value of each signal from the baseline value of each signal, wherein the peak value is determined as an average of at least one sample taken only around the peak during the sampling period, and the baseline value is determined as an average of at least one sample taken only around the beginning or end of the sampling period.

Abstract: A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis.

Abstract: A PET event position calculation method using a combination angular and radial event map wherein identification of the radial distance of the event from the centroid of the scintillation crystal with which the event is associated as well as angular information is performed. The radial distance can be converted to a statistical confidence interval, which information can be used in downstream processing. More sophisticated reconstruction algorithms can use the confidence interval information selectively, to generate higher fidelity images with higher confidence information, and to improve statistics in dynamic imaging with lower confidence information.

Abstract: A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis.

Abstract: A sample card and automated quality control module for a radiopharmaceutical synthesis system for conducting quality control tests on approximately one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography. The sample card and quality control module allow operators to conduct quality control tests in reduced time using micro-scale test samples from the radiopharmaceutical solution. The sample card works in conjunction with a microfluidic radiopharmaceutical synthesis system to collect samples of radiopharmaceutical solution on the scale of 5-20 microliters per sample. The sample card then interacts with the quality control module to feed the samples into a number of test vessels, where the samples undergo a number of automated quality control tests.

Abstract: A PET event position calculation method using a combination angular and radial event map wherein identification of the radial distance of the event from the centroid of the scintillation crystal with which the event is associated as well as angular information is performed. The radial distance can be converted to a statistical confidence interval, which information can be used in downstream processing. More sophisticated reconstruction algorithms can use the confidence interval information selectively, to generate higher fidelity images with higher confidence information, and to improve statistics in dynamic imaging with lower confidence information.

Abstract: A PET event position calculation method using a combination angular and radial event map wherein identification of the radial distance of the event from the centroid of the scintillation crystal with which the event is associated as well as angular information is performed. The radial distance can be converted to a statistical confidence interval, which information can be used in downstream processing. More sophisticated reconstruction algorithms can use the confidence interval information selectively, to generate higher fidelity images with higher confidence information, and to improve statistics in dynamic imaging with lower confidence information.

Abstract: A method for processing events in a medical imaging device may comprise the steps of receiving analog signals from at least one PMT into an Applied Specific Integrated Circuit (ASIC) comprising a Constant Fraction Discriminator (CFD) and transmitting analog outputs from the ASIC. Further, sampling the analog outputs continuously using an Analog to Digital Converter (ADC) and transmitting digital outputs; and collecting a number of samples of the digital output during a sampling period using a Field Programmable Gate Array (FPGA) when triggered by the CFD. The method may additionally determine the energy of the analog signals from the at lease one PMT by subtracting the peak value of each signal from the baseline value of each signal, wherein the peak value is determined as an average of at least one sample taken only around the peak during the sampling period, and the baseline value is determined as an average of at least one sample taken only around the beginning or end of the sampling period.

Abstract: A PET event position calculation method using a combination angular and radial event map wherein identification of the radial distance of the event from the centroid of the scintillation crystal with which the event is associated as well as angular information is performed. The radial distance can be converted to a statistical confidence interval, which information can be used in downstream processing. More sophisticated reconstruction algorithms can use the confidence interval information selectively, to generate higher fidelity images with higher confidence information, and to improve statistics in dynamic imaging with lower confidence information.