[Approval procedures for clinical trials in the field of radiation oncology]. / Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie.

BACKGROUND AND PURPOSE: Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. METHODS: A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. RESULTS: Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials. CONCLUSION: An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.

Multiple procedures and cumulative individual radiation exposure in interventional cardiology: A long-term retrospective study.

INTRODUCTION: Various studies address discrepancies between guideline recommendations for coronary angiographies and clinical practice. While the issue of the appropriateness of recurrent angiographies was studied focusing on the role of the cardiologist, little is known about individual patients' histories and the associated radiation exposures. METHODS: We analyzed all patients with coronary artery disease (CAD) in an academic teaching practice who underwent at least one angiography with or without intervention between 2004 and 2009. All performed angiographies in these patients were analyzed and rated by three physicians for appropriateness levels according to cardiology guidelines. Typical exposure data from the medical literature were used to estimate individual radiation exposure. RESULTS: In the cohort of 147 patients, a total of 441 procedures were analyzed: between 1981 and 2009, three procedures were performed per patient (range 1-19) on average. Appropriateness ratings were 'high/intermediate' in 71%, 'low/no' in 27.6% and data were insufficient for ratings in 1.4%. Procedures with 'low/no' ratings were associated with potentially avoidable exposures of up to 186 mSv for single patients. CONCLUSIONS: Using retrospective data, we exemplify the potential benefit of guideline adherence to decrease patients' radiation exposures. KEY POINTS: • A cohort study of 147 patients showed 27.6% low appropriateness procedures. • Potentially avoidable radiation exposure cumulated up to about 186 mSv for single patients. • Predisposing factors were prior bypass surgery and first treatment in a tertiary centre. • 7.5% of the patients received 58% of the potentially avoidable radiation exposure. • The benefits of guideline adherence in decreasing patient radiation exposure are exemplified.

Radiation risk and protection of patients in clinical SPECT/CT.

Clinical studies have demonstrated that hybrid single photon emission computed tomography (SPECT)/CT for various diagnostic issues has an added value as compared to SPECT alone. However, the combined acquisition of functional and anatomical images can substantially increase radiation exposure to patients, in particular when using a hybrid system with diagnostic CT capabilities. It is, therefore, essential to carefully balance the diagnostic needs and radiation protection requirements. To this end, the evidence on health effects induced by ionizing radiation is outlined. In addition, the essential concepts for estimating radiation doses and lifetime attributable cancer risks associated with SPECT/CT examinations are presented taking into account both the new recommendations of the International Commission on Radiological Protection (ICRP) as well as the most recent radiation risk models. Representative values of effective dose and lifetime attributable risk are reported for ten frequently used SPECT radiopharmaceuticals and five fully diagnostic partial-body CT examinations. A diagnostic CT scan acquired as part of a combined SPECT/CT examination contributes considerably to, and for some applications even dominates, the total patient exposure. For the common SPECT and CT examinations considered in this study, the lifetime attributable risk of developing a radiation-related cancer is less than 0.27 %/0.37 % for men/women older than 16 years, respectively, and decreases markedly with increasing age at exposure. Since there is no clinical indication for a SPECT/CT examination unless an emission scan has been indicated, the issue on justification comes down to the question of whether it is necessary to additionally acquire a low-dose CT for attenuation correction and anatomical localization of tracer uptake or even a fully diagnostic CT. In any case, SPECT/CT studies have to be optimized, e.g. by adapting dose reduction measures from state-of-the-art CT practice, and exposure levels should not exceed the national diagnostic reference levels for standard situations.

Significant incidents during X-ray exposures in humans - assessment and findings of the Federal Office for Radiation Protection. / Bedeutsame Vorkommnisse bei Röntgenanwendungen am Menschen ­ Auswertungen und Erkenntnisse des BfS.

In Germany, significant incidents must be reported to the competent authority since 12/31/2018 (section 108 Radiation Protection Ordinance (StrlSchV)). After assessment and evaluation of the reports, the competent authority submits the relevant information via a web-based reporting system (BeVoMed) to the Federal Office for Radiation Protection (BfS), which publishes the results derived therefrom. The present paper evaluates significant incidents related to X-ray exposures on humans.All reports on incidents in X-ray diagnostics and interventional radiology between 01/2019 and 10/2023, which were completed with detailed information until the reporting day (31/10/2023), were included. The following aspects were statistically evaluated: classification as an incident (section 1 subsection (22) StrlSchV), significance (section 108 StrSchV), classification to Annex 14 StrlSchV, assignment to the forms of care in the German healthcare system, and development of the reporting frequency over time. Furthermore, the content of the reports was systematically evaluated with regard to conspicuous clusters and typical problems.Until the reporting day, 383 reports (355 completed) were received. 252 reports (228 in X-ray diagnostics, 24 in interventional radiology) referred to significant incidents and were included in the detailed evaluation. Reporting frequency increased in X-ray diagnostics, whereas there was no trend in interventional radiology. Most of the significant incidents concerned examinations on an individual person (category I, criterion 2a or category II, criteria 2a and 3a) in the in-patient sector - especially in maximum care hospitals. Frequent errors concerned the inappropriate choice of parameters/protocols or were related to the administration of a contrast agent. Despite the overall positive trend, the establishment of awareness and error culture remains challenging. · In X-ray diagnostics, the reporting frequency of significant incidents increases.. · Most incidents concerned CT examinations in the in-patient sector.. · Main problems were selection of protocols/settings, contrast administration, and bolus-tracking.. · Uncertainties remain about the classification of an incident as significant and notifiable.. · Winter KS, Schweden M, Brix G et al. Significant incidents during X-ray exposures in humans - assessment and findings of the Federal Office for Radiation Protection. Fortschr Röntgenstr 2024; DOI 10.1055/a-2339-3684.

Reproduction of a conventional anthropomorphic female chest phantom by 3D-printing: Comparison of image contrasts and absorbed doses in CT.

BACKGROUND: The production of individualized anthropomorphic phantoms via three-dimensional (3D) printing methods offers promising possibilities to assess and optimize radiation exposures for specifically relevant patient groups (i.e., overweighed or pregnant persons) that are not adequately represented by standardized anthropomorphic phantoms. However, the equivalence of printed phantoms must be demonstrated exemplarily with respect to the resulting image contrasts and dose distributions. PURPOSE: To reproduce a conventionally produced anthropomorphic phantom of a female chest and breasts and to evaluate their equivalence with respect to image contrasts and absorbed doses at the example of a computed tomography (CT) examination of the chest. METHODS: In a first step, the effect of different print settings on the CT values of printed samples was systematically investigated. Subsequently, a transversal slice and breast add-ons of a conventionally produced female body phantom were reproduced using a multi-material extrusion-based printer, considering six different types of tissues (muscle, lung, adipose, and glandular breast tissue, as well as bone and cartilage). CT images of the printed and conventionally produced phantom parts were evaluated with respect to their geometric correspondence, image contrasts, and absorbed doses measured using thermoluminescent dosimeters. RESULTS: CT values of printed objects are highly sensitive to the selected print settings. The soft tissues of the conventionally produced phantom could be reproduced with a good agreement. Minor differences in CT values were observed for bone and lung tissue, whereas absorbed doses to the relevant tissues were identical within the measurement uncertainties. CONCLUSION: 3D-printed phantoms are with exception of minor contrast differences equivalent to their conventionally manufactured counterparts. When comparing the two production techniques, it is important to note that conventionally manufactured phantoms should not be considered as absolute benchmarks, as they also only approximate the human body in terms of its absorption, and attenuation of x-rays as well as its geometry.

Dose-efficiency quantification of computed tomography systems using a model-observer.

BACKGROUND: Recent advances in computed tomography (CT) technology have considerably improved the quality of CT images and reduced radiation exposure in patients. At present, however, there is no generally accepted figure of merit (FOM) for comparing the dose efficiencies of CT systems. PURPOSE: (i) To establish an FOM that characterizes the quality of CT images in relation to the radiation dose by means of a mathematical model observer and (ii) to evaluate the new FOM on different CT systems and image reconstruction algorithms. METHODS: Images of a homogeneous phantom with four low-contrast inserts were acquired using three different CT systems at three dose levels and a representative protocol for CT imaging of low-contrast objects in the abdomen. The images were reconstructed using filtered-back projection and iterative algorithms. A channelized hotelling observer with difference-of-Gaussian channels was applied to compute the detectability ( d ' $d^{\prime}$ ). This was done for each insert and each of the considered imaging conditions from square regions of interest (ROIs) that were (semi-)automatically centered on the inserts. The estimated detectabilities ( d ' $d^{\prime}$ ) were averaged in the first step over the three dose levels ( ⟨ d ' ⟩ $\langle {d^{\prime}} \rangle $ ), and subsequently over the four contrast inserts ( ⟨ d ' ⟩ w ${\langle {d^{\prime}} \rangle _{\rm{w}}}$ ). All calculation steps included a dedicated assessment of the related uncertainties following accepted metrological guidelines. RESULTS: The determined detectabilities ( d ' $d^{\prime}$ ) varied considerably with the contrast and diameter of the four inserts, as well as with the radiation doses and reconstruction algorithms used for image generation ( d ' $d^{\prime}\;$ = 1.3-5.5). Thus, the specification of a single detectability as an FOM is not well suited for comprehensively characterizing the dose efficiency of a CT system. A more comprehensive and robust characterization was provided by the averaged detectabilities ⟨ d ' ⟩ $\langle {d^{\prime}} \rangle $ and, in particular, ⟨ d ' ⟩ w ${\langle {d^{\prime}} \rangle _{\rm{w}}}$ . Our analysis reveals that the model observer analysis is very sensitive to the exact position of the ROIs. CONCLUSIONS: The presented automatable software approach yielded with the weighted detectability ⟨ d ' ⟩ w ${\langle {d^{\prime}} \rangle _{\rm{w}}}$ an objective FOM to benchmark different CT systems and reconstruction algorithms in a robust and reliable manner. An essential advantage of the proposed model-observer approach is that uncertainties in the FOM can be provided, which is an indispensable prerequisite for type testing.

Improving pulmonary perfusion assessment by dynamic contrast-enhanced computed tomography in an experimental lung injury model.

Pulmonary perfusion has been poorly characterized in acute respiratory distress syndrome (ARDS). Optimizing protocols to measure pulmonary blood flow (PBF) via dynamic contrast-enhanced (DCE) computed tomography (CT) could improve understanding of how ARDS alters pulmonary perfusion. In this study, comparative evaluations of injection protocols and tracer-kinetic analysis models were performed based on DCE-CT data measured in ventilated pigs with and without lung injury. Ten Yorkshire pigs (five with lung injury, five healthy) were anesthetized, intubated, and mechanically ventilated; lung injury was induced by bronchial hydrochloric acid instillation. Each DCE-CT scan was obtained during a 30-s end-expiratory breath-hold. Reproducibility of PBF measurements was evaluated in three pigs. In eight pigs, undiluted and diluted Isovue-370 were separately injected to evaluate the effect of contrast viscosity on estimated PBF values. PBF was estimated with the peak-enhancement and the steepest-slope approach. Total-lung PBF was estimated in two healthy pigs to compare with cardiac output measured invasively by thermodilution in the pulmonary artery. Repeated measurements in the same animals yielded a good reproducibility of computed PBF maps. Injecting diluted isovue-370 resulted in smaller contrast-time curves in the pulmonary artery (P < 0.01) and vein (P < 0.01) without substantially diminishing peak signal intensity (P = 0.46 in the pulmonary artery) compared with the pure contrast agent since its viscosity is closer to that of blood. As compared with the peak-enhancement model, PBF values estimated by the steepest-slope model with diluted contrast were much closer to the cardiac output (R2 = 0.82) as compared with the peak-enhancement model. DCE-CT using the steepest-slope model and diluted contrast agent provided reliable quantitative estimates of PBF.NEW & NOTEWORTHY Dynamic contrast-enhanced CT using a lower-viscosity contrast agent in combination with tracer-kinetic analysis by the steepest-slope model improves pulmonary blood flow measurements and assessment of regional distributions of lung perfusion.

Lung Cancer Screening with Low-Dose CT: Radiation Risk and Benefit-Risk Assessment for Different Screening Scenarios.

Lung cancer is a severe disease that affects predominantly smokers and represents a leading cause of cancer death in Europe. Recent meta-analyses of randomized controlled trials (RCTs) have yielded that low-dose computed tomography (LDCT) screening can significantly reduce lung cancer mortality in heavy smokers or ex-smokers by about 20% compared to a control group of persons who did not receive LDCT. This benefit must be weighed against adverse health effects associated with LDCT lung screening, in particular radiation risks. For this purpose, representative organ doses were determined for a volume CT dose index of 1 mGy that can be achieved on modern devices. Using these values, radiation risks were estimated for different screening scenarios by means of sex-, organ-, and age-dependent radio-epidemiologic models. In particular, the approach was adjusted to a Western European population. For an annual LDCT screening of (ex-)smokers aged between 50 and 75 years, the estimated radiation-related lifetime attributable risk to develop cancer is below 0.25% for women and about 0.1% for men. Assuming a mortality reduction of about 20% and taking only radiation risks into account, this screening scenario results in a benefit-risk ratio of about 10 for women and about 25 for men. These benefit-risk ratio estimates are based on the results of RCTs of the highest evidence level. To ensure that the benefit outweighs the radiation risk even in standard healthcare, strict conditions and requirements must be established for the entire screening process to achieve a quality level at least as high as that of the considered RCTs.

Tissue equivalence of 3D printing materials with respect to attenuation and absorption of X-rays used for diagnostic and interventional imaging.

INTRODUCTION: Three-dimensional printing is a promising technology to produce phantoms for quality assurance and dosimetry in X-ray imaging. Crucial to this, however, is the use of tissue equivalent printing materials. It was thus the aim of this study to evaluate the properties of a larger number of commercially available printing filaments with respect to their attenuation and absorption of X-rays. MATERIALS AND METHODS: Apparent kerma attenuation coefficients (AKACs) and absorbed doses for different X-ray spectra (tube voltages, 70-140 kV) were measured and simulated by Monte-Carlo computations for a larger number of fused-deposition-modeling (FDM) materials. The results were compared with the respective values simulated for reference body tissues. In addition, the properties of polylactide acid samples printed with reduced infill densities were investigated. RESULTS: Measured and simulated AKACs and absorbed doses agreed well with each other and in case of AKACs also with attenuation coefficients derived from the reference database of the National Institute of Standards and Technology (NIST). For lung, adipose, muscle, and bulk soft tissue as well as for spongiosa (cancellous bone), printed materials with equivalent attenuation as well as absorption properties could be identified. In contrast, none of the considered printed materials was equivalent to cortical bone. CONCLUSION: Several FDM materials have been identified as well-suited substitutes for body tissues in terms of the investigated material characteristics. They can therefore be used for in-house production of individualized and task-specific phantoms for image quality assessment and dose measurements in X-ray imaging.

Radiation dose at coronary CT angiography: second-generation dual-source CT versus single-source 64-MDCT and first-generation dual-source CT.

OBJECTIVE: The purpose of this study was to assess the radiation doses of different coronary CTA (CTA) protocols: second-generation dual-source 128-MDCT, first-generation dual-source 64-MDCT, and single-source 64-MDCT. MATERIALS AND METHODS: Thermoluminescent dosimetry was used to determine scanner-specific dose coefficients for standard coronary CTA of an anthropomorphic phantom. These coefficients were used to estimate the effective doses (EDs) of retrospectively gated, prospectively triggered, and prospectively triggered high pitch coronary CTA performed at 100 and 120 kV. The coronary CTA protocols used in imaging of 43 patients undergoing dual-source 128-MDCT were analyzed for ED, image quality, and signal-to-noise ratio. RESULTS: Regardless of coronary CTA protocol and CT system, imaging at 100 kV lowered the ED 40-50%. In retrospectively gated 120-kV coronary CTA, the ED ranged from 5.7 to 10.7 mSv and was approximately 50% lower with single-source 64-MDCT than with either DSCT protocol. In prospectively triggered 120-kV coronary CTA, the ED ranged from 3.8 to 4.0 mSv. The lowest ED of all protocols (1.3 mSv) was observed in prospectively triggered high-pitch 100-kV coronary CTA performed with dual-source 128-MDCT. Patient measurements showed similar dose reductions for prospective triggering and low voltage settings without an influence on signal-to-noise ratio or image quality. CONCLUSION: A combination of prospective triggering with low voltage settings is an effective measure for reducing the ED of coronary CTA to values of 2-4 mSv independent of scanner system. Further dose reduction to nearly 1 mSv can be achieved with high-pitch prospectively triggered coronary CTA.

Lung Cancer Screening with Low-Dose CT in Smokers: A Systematic Review and Meta-Analysis.

Lung cancer continues to be one of the main causes of cancer death in Europe. Low-dose computed tomography (LDCT) has shown high potential for screening of lung cancer in smokers, most recently in two European trials. The aim of this review was to assess lung cancer screening of smokers by LDCT with respect to clinical effectiveness, radiological procedures, quality of life, and changes in smoking behavior. We searched electronic databases in April 2020 for publications of randomized controlled trials (RCT) reporting on lung cancer and overall mortality, lung cancer morbidity, and harms of LDCT screening. A meta-analysis was performed to estimate effects on mortality. Forty-three publications on 10 RCTs were included. The meta-analysis of eight studies showed a statistically significant relative reduction of lung cancer mortality of 12% in the screening group (risk ratio = 0.88; 95% CI: 0.79-0.97). Between 4% and 24% of screening-LDCT scans were classified as positive, and 84-96% of them turned out to be false positive. The risk of overdiagnosis was estimated between 19% and 69% of diagnosed lung cancers. Lung cancer screening can reduce disease-specific mortality in (former) smokers when stringent requirements and quality standards for performance are met.

Tracer kinetic modelling of tumour angiogenesis based on dynamic contrast-enhanced CT and MRI measurements.

PURPOSE: Technical developments in both magnetic resonance imaging (MRI) and computed tomography (CT) have helped to reduce scan times and expedited the development of dynamic contrast-enhanced (DCE) imaging techniques. Since the temporal change of the image signal following the administration of a diffusible, extracellular contrast agent (CA) is related to the local blood supply and the extravasation of the CA into the interstitial space, DCE imaging can be used to assess tissue microvasculature and microcirculation. It is the aim of this review to summarize the biophysical and tracer kinetic principles underlying this emerging imaging technique offering great potential for non-invasive characterization of tumour angiogenesis. METHODS: In the first part, the relevant contrast mechanisms are presented that form the basis to relate signal variations measured by serial CT and MRI to local tissue concentrations of the administered CA. In the second part, the concepts most widely used for tracer kinetic modelling of concentration-time courses derived from measured DCE image data sets are described in a consistent and unified manner to highlight their particular structure and assumptions as well as the relationships among them. Finally, the concepts presented are exemplified by the analysis of representative DCE data as well as discussed with respect to present and future applications in cancer diagnosis and therapy. RESULTS: Depending on the specific protocol used for the acquisition of DCE image data and the particular model applied for tracer kinetic analysis of the derived concentration-time courses, different aspects of tumour angiogenesis can be quantified in terms of well-defined physiological tissue parameters. CONCLUSIONS: DCE imaging offers promising prospects for improved tumour diagnosis, individualization of cancer treatment as well as the evaluation of novel therapeutic concepts in preclinical and early-stage clinical trials.

Estimation of tissue perfusion by dynamic contrast-enhanced imaging: simulation-based evaluation of the steepest slope method.

OBJECTIVE: Tissue perfusion is frequently determined from dynamic contrast-enhanced CT or MRI image series by means of the steepest slope method. It was thus the aim of this study to systematically evaluate the reliability of this analysis method on the basis of simulated tissue curves. METHODS: 9600 tissue curves were simulated for four noise levels, three sampling intervals and a wide range of physiological parameters using an axially distributed reference model and subsequently analysed by the steepest slope method. RESULTS: Perfusion is systematically underestimated with errors becoming larger with increasing perfusion and decreasing intravascular volume. For curves sampled after rapid contrast injection with a temporal resolution of 0.72 s, the bias was less than 23% when the mean residence time of tracer molecules in the intravascular distribution space was greater than 6 s. Increasing the sampling interval and the noise level substantially reduces the accuracy and precision of estimates, respectively. CONCLUSIONS: The steepest slope method allows absolute quantification of tissue perfusion in a computationally simple and numerically robust manner. The achievable degree of accuracy and precision is considered to be adequate for most clinical applications.

Simulation-based comparison of two approaches frequently used for dynamic contrast-enhanced MRI.

PURPOSE: The purpose was to compare two approaches for the acquisition and analysis of dynamic-contrast-enhanced MRI data with respect to differences in the modelling of the arterial input-function (AIF), the dependency of the model parameters on physiological parameters and their numerical stability. Eight hundred tissue concentration curves were simulated for different combinations of perfusion, permeability, interstitial volume and plasma volume based on two measured AIFs and analysed according to the two commonly used approaches. The transfer constants (Approach 1) K (trans) and (Approach 2) k (ep) were correlated with all tissue parameters. K (trans) showed a stronger dependency on perfusion, and k (ep) on permeability. The volume parameters (Approach 1) v (e) and (Approach 2) A were mainly influenced by the interstitial and plasma volume. Both approaches allow only rough characterisation of tissue microcirculation and microvasculature. Approach 2 seems to be somewhat more robust than 1, mainly due to the different methods of CA administration.

Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example. / Früherkennung von Krankheiten mittels radiologischer Bildgebung: Neue Rechtslage und Bewertung von Leistungsangeboten am Beispiel von CT-Untersuchungen.

BACKGROUND: Radiological imaging offers promising prospects for the early detection of diseases. In Germany, the legal framework for such examinations was created by the Radiation Protection Law, which entered into force on December 31, 2018. Under this law, each specific type of radiodiagnostic screening of non-communicable diseases needs an approval on a generic level (permission) by a federal statutory ordinance, defining the specific requirements and conditions. It is the aim of the present paper, (i) to present in detail the new legal situation and (ii) to assess actual service offers for the screening of asymptomatic persons using CT examinations as an example. METHOD: In February 2019, radiology institutions in Germany illegally offering on the Internet CT examinations for the screening of lung and colon cancer or coronary artery disease were identified. For each type of examination, 50 pertinent websites were evaluated particularly regarding the general information on the offered screening examination and the concrete procedure. RESULTS: In the vast majority of cases, the information provided on the websites was inadequate and disproportionately emphasized the benefits over the risks of the screening examination. Moreover, the offers differed substantially with respect to the age and risks factors of potential participants, the frequency of examinations, the screening procedure, and the diagnostic workup. CONCLUSION: The evaluated service offers strongly substantiate the need to define requirements and conditions regarding radiological screening examinations by statutory ordinances, in order to ensure an informed decision of potential screening participants as well as the benefit versus the risks of the procedures. KEY POINTS: · High-evidence studies prove the benefit of radiological screening for some diseases.. · In Germany, screening examinations are only permissible when stated in a federal statutory ordinance.. · At present, only mammography screening for breast cancer is permitted in Germany.. · CT screening examinations currently being conducted in Germany do not fulfill the legal and professional requirements.. · A review process has been initiated regarding possible generic approval of lung cancer screening.. CITATION FORMAT: · Brix G, Nekolla EA, Griebel J. Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example. Fortschr Röntgenstr 2020; 192: 139 - 148.

Double-strand breaks in lymphocyte DNA of humans exposed to [18F]fluorodeoxyglucose and the static magnetic field in PET/MRI.

BACKGROUND: Given the increasing clinical use of PET/MRI, potential risks to patients from simultaneous exposure to ionising radiation and (electro)magnetic fields should be thoroughly investigated as a precaution. With this aim, the genotoxic potential of 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG) and a strong static magnetic field (SMF) were evaluated both in isolation and in combination using the γH2AX assay detecting double-strand breaks in lymphocyte DNA. METHODS: Thirty-two healthy young volunteers allocated to three study arms were exposed to [18F]FDG alone, to a 3-T SMF alone or to both combined over 60 min at a PET/CT or a PET/MRI system. Blood samples taken after in vivo exposure were incubated up to 60 min to extend the irradiation of blood by residual [18F]FDG within the samples and the time to monitor the γH2AX response. Absorbed doses to lymphocytes delivered in vivo and in vitro were estimated individually for each volunteer exposed to [18F]FDG. γH2AX foci were scored automatically by immunofluorescence microscopy. RESULTS: Absorbed doses to lymphocytes exposed over 60 to 120 min to [18F]FDG varied between 1.5 and 3.3 mGy. In this time interval, the radiotracer caused a significant median relative increase of 28% in the rate of lymphocytes with at least one γH2AX focus relative to the background rate (p = 0.01), but not the SMF alone (p = 0.47). Simultaneous application of both agents did not result in a significant synergistic or antagonistic outcome (p = 0.91). CONCLUSION: There is no evidence of a synergism between [18F]FDG and the SMF that may be of relevance for risk assessment of PET/MRI.

COPD Imaging on a 3rd Generation Dual-Source CT: Acquisition of Paired Inspiratory-Expiratory Chest Scans at an Overall Reduced Radiation Risk.

As stated by the Fleischner Society, an additional computed tomography (CT) scan in expiration is beneficial in patients with chronic obstructive pulmonary disease (COPD). It was thus the aim of this study to evaluate the radiation risk of a state-of-the-art paired inspiratory-expiratory chest scan compared to inspiration-only examinations. Radiation doses to 28 organs were determined for 824 COPD patients undergoing routine chest examinations at three different CT systems-a conventional multi-slice CT (MSCT), a 2nd generation (2nd-DSCT), and 3rd generation dual-source CT (3rd-DSCT). Patients examined at the 3rd-DSCT received a paired inspiratory-expiratory scan. Organ doses, effective doses, and lifetime attributable cancer risks (LAR) were calculated. All organ and effective doses were significantly lower for the paired inspiratory-expiratory protocol (effective doses: 4.3 ± 1.5 mSv (MSCT), 3.0 ± 1.2 mSv (2nd-DSCT), and 2.0 ± 0.8 mSv (3rd-DSCT)). Accordingly, LAR was lowest for the paired protocol with an estimate of 0.025 % and 0.013% for female and male patients (50 years) respectively. Image quality was not compromised. Paired inspiratory-expiratory scans can be acquired on 3rd-DSCT systems at substantially lower dose and risk levels when compared to inspiration-only scans at conventional CT systems, offering promising prospects for improved COPD diagnosis.

Risks and safety aspects related to PET/MR examinations.

INTRODUCTION: The introduction of positron emission tomography (PET)/magnetic resonance (MR) systems into medical practice in the foreseeable future may not only lead to a gain in clinical diagnosis compared to PET/computed tomography (CT) imaging due to the superior soft-tissue contrast of the MR technology but can also substantially reduce exposure of patients to ionizing radiation. On the other hand, there are also risks and health effects associated with the use of diagnostic MR devices that have to be considered carefully. OBJECTIVES: This review article summarizes biophysical and biological aspects, which are of relevance for the assessment of health effects related to the exposure of patients to both ionizing radiation in PET and magnetic and electromagnetic fields in MR. On this basis, some considerations concerning the justification and optimization of PET/MR examinations are presented--as far as this is possible at this very early stage. DISCUSSION: Current safety standards do not take into account synergistic effects of ionizing radiation and magnetic and electromagnetic fields. In the light of the developing PET/MR technology, there is an urgent need to investigate this aspect in more detail for exposure levels that will occur at PET/MR systems.

Radiation exposure of medical staff from interventional x-ray procedures: a multicentre study.

The purpose of this study was to analyse the radiation exposure of medical staff from interventional x-ray procedures. Partial-body dose measurements were performed with thermoluminescent dosimeters (TLD) in 39 physicians and nine assistants conducting 73 interventional procedures of nine different types in 14 hospitals in Germany. Fluoroscopy time and the dose-area product (DAP) were recorded too. The median (maximum) equivalent body dose per procedure was 16 (2,500) microSv for an unshielded person; the partial-body dose per procedure was 2.8 (240) microSv to the eye lens, 4.1 (730) microSv to the thyroid, 44 (1,800) microSv to one of the feet and 75 (13,000) microSv to one of the hands. A weak correlation between fluoroscopy time or DAP and the mean TLD dose was observed. Generally, the doses were within an acceptable range from a radiation hygiene point of view. However, relatively high exposures were measured to the hand in some cases and could cause a partial-body dose above the annual dose limit of 500 mSv. Thus, the use of finger dosimeters is strongly recommended.