National survey to update the diagnostic reference levels in interventional radiology procedures in Italy: working methodology.

Interventional Radiology (IR) deals with the diagnosis and treatment of various diseases through medically guided imaging. It provides unquestionable benefits to patients, but requires, in many cases, the use of high doses of ionizing radiation with a high impact on radiation risks to patients and to overall dose to the population. The International Commission on Radiological Protection introduced Diagnostic reference levels (DRLs) as an effective tool to facilitate dose verification and optimize protection for patients undergoing radiological procedures. In addition, EURATOM Council Directive 2013/59 and its Italian transposition (Legislative Decree 101/2020) have reiterated that DRLs must be established for many common radiological diagnostic procedures to compare the radiation dose delivered for the same diagnostic examination. Within this framework, Istituto Superiore di Sanità-Italian National Institute of Health (ISS)-, in collaboration with relevant Italian Scientific Societies, has provided documents on DRLs in radiological practices such as diagnostic and IR and diagnostic nuclear medicine. These reference documents enable National Hospitals to comply national regulation. The implementation of DRLs in IR is a difficult task because of the wide distribution of doses to patients even within the same procedure. Some studies have revealed that the amount of radiation in IR procedures is influenced more by the complexity of the procedure than by the weight of the patient, so complexity should be included in the definition of DRLs. For this reason, ISS promoted a survey among a sample of Italian Centers update national DRL in IR procedures with related complexity factors than can be useful for other radiological centers and to standardize the DRLs values. In the present paper the procedural methodology developed by ISS and used for the survey will be illustrated.

Miniaturized implantable sensors for in vivo localized temperature measurements in mice during cold exposure.

We report on in vivo temperature measurements performed in mice at two specific sites of interest in the animal body over a period of several hours. In particular, the aim of this work was to monitor mouse metabolism during cold exposure, and to record possible temperature differences between the body temperature measured in the abdomen and the temperature of the brown adipose tissue (BAT) situated in the interscapular area. This approach is of biological interest as it may help unravelling the question whether biochemical activation of BAT is associated with local increase in metabolic heat production. For that purpose, miniaturized thermistor sensors have been accurately calibrated and implanted in the BAT and in the abdominal tissue of mice. After 1 week of recovery from surgery, mice were exposed to cold (6 °C) for a maximum duration of 6 h and the temperature was acquired continuously from the two sensors. Control measurements with a conventional rectal probe confirmed good performance of both sensors. Moreover, two different mouse phenotypes could be identified, distinguishable in terms of their metabolic resistance to cold exposure. This difference was analyzed from the thermal point of view by computational simulations. Our simple physical model of the mouse body allowed to reproduce the global evolution of hypothermia and also to explain qualitatively the temperature difference between abdomen and BAT locations. While with our approach, we have demonstrated the importance and feasibility of localized temperature measurements on mice, further optimization of this technique may help better identify local metabolism variations.

[Repetitive transcranial magnetic stimulation in major depression: response factor]. / Stimulation magnétique transcrânienne répétée dans la prise en charge des épisodes dépressifs majeurs : facteurs prédictifs de réponse thérapeutique.

OBJECTIVE: Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique that has been investigated as a novel treatment for psychiatric disorders, notably in major depression, and has shown statistically significant effects. The authors found it necessary to propose an up-to-date review of positive predictors for antidepressive response to repetitive transcranial magnetic stimulation. METHOD: Based on an exhaustive consultation of Medline data, supplemented by a manual research, only works evaluating response factors of rTMS in major depression were retained. RESULTS: Twenty-nine studies were retained, including meta-analyses, reviews, randomized controlled trials and open trials. The most concordant data clearly indicate that a high score of treatment resistance, a long duration of current episode, advanced age, and psychotic symptoms are negative predictors for treatment response to rTMS. In the older patients, menopausal women are especially concerned. However, some parameters should be adapted to the degree of cortical atrophy such as intensity of stimulation or total number of rTMS sessions. Previous response to rTMS therapy seems to be a good predictor contrary to non-response to electroconvulsive therapy. Adjunctive antidepressant treatment shows greater responsiveness to rTMS contrary to benzodiazepine or anticonvulsant treatment. To our knowledge, no study compares unipolar and bipolar depression, the profile of depression is not established yet. Imaging studies show that TMS antidepressant responders differed from non-responders in inferior frontal activity, at baseline, and even more so following treatment. Furthermore, reduced baseline cerebral metabolism in cerebellar, temporal, anterior cingulate and occipital regions of the brain was correlated with improvement after two weeks of fast (20Hz) left dorsolateral prefrontal cortex (DLPFC) rTMS. Additionally, a right frontal region emerges with divergent polarity in the metabolic prediction of response to low rTMS. Inhibiting right DLPFC or stimulating DLPFC shows similar results, the choice on the side of stimulation does not seem determining. Bilateral stimulation for the moment does not seem superior to unilateral stimulation. Parameters of stimulation associated with effectiveness of rTMS are an intensity of stimulation higher than 100% of the motor threshold, a number of stimulations per sessions superior to 1000, and a full number of days of treatment greater than 10. DISCUSSION: Parameters of stimulation must be adapted according to the treated patients. For example, older patients who present cortical atrophy need higher intensity of stimulation. Other criteria could influence effectiveness of rTMS in the same way. Would it be necessary, for example, to adapt the duration or the intensity of stimulation according to the severity of the depressive episode or its duration of evolution? Do antecedents of resistance to a pharmacological treatment oblige us to stimulate differently? Few studies exceed 10 days of treatment; will longer duration of treatment be more effective? Also, we did not find any data on the interest of maintenance treatment among responders. Should the characteristics of the depressive disorder or its evolution require maintenance treatment? What will be its rhythm and its duration? Should we adapt rTMS parameters to abnormalities highlighted by functional neuroimagery? The prospects for work remain numerous.

A cutoff thyroglobulin value suggestive of distant metastases in differentiated thyroid cancer patients.

Serum thyroglobulin is used as part of the early postoperative assessment of differentiated thyroid cancer (DTC) since there is a clear relationship between an increased risk of recurrence and persistent disease after initial treatment and high postoperative stimulated thyroglobulin (ps-Tg) values. Thus, although ps-Tg above 10-30 ng/mL is considered an independent predictor of worse prognosis, the value that is associated with distant metastases is not defined. Thus, this was our objective. We selected 655 DTC patients from a nuclear medicine department database (Irmandade Santa Casa de Misericórdia de São Paulo, Brazil). All patients had received total thyroidectomy and radioactive iodine (RAI) therapy and had ps-Tg values higher than 10 ng/mL with negative anti-thyroglobulin antibodies. Then, we selected patients who presented post-therapy whole-body scan with pulmonary and/or bone uptake but with no mediastinum or cervical uptake. Patients with negative findings on functional imaging or any doubt on lung/bone uptake were submitted to additional exams to exclude another non-thyroid tumor. Of the 655 patients, 14.3% had pulmonary and 4.4% bone metastases. There was a significant difference in ps-Tg levels between patients with and without metastases (P<0.001). The cutoff value of ps-Tg was 117.5 ng/mL (sensitivity: 70.2%; specificity: 71.7%) for those with lung metastasis, and 150.5 ng/mL (sensitivity: 79.3%; specificity: 85%) for those with bone metastasis. The cutoff value for patients with eitherpulmonary or bone metastasis was 117.5 ng/mL (sensitivity: 70.2%; specificity: 83.7%). Our findings demonstrated that ps-Tg could predict distant metastasis in DTC patients. We identified a cutoff of 117.5 ng/mL with a high negative predictive value of 93.7%.

A pilot study exploring the possibility of establishing guidance levels in x-ray directed interventional procedures.

This article summarizes the dosimetric results of an International Atomic Energy Agency coordinated research program to investigate the feasibility of adopting guidance levels for invasive coronary artery procedures. The main study collected clinical data from hospitals located in five countries. A total of 2265 coronary angiograms (CA) and 1844 percutaneous coronary interventions (PCI) were analyzed. Substudies evaluated the dosimetric performance of 14 fluoroscopes, skin dose maps obtained using film, the quality of CA procedures, and the complexity of PCI procedures. Kerma-area product (PKA) guidance levels of 50 and 125 Gy cm2 are suggested for CA and PCI procedures. These levels should be adjusted for the complexity of the procedures performed in a given institution.

An international calibration of Kerma-Area Product meters for patient dose optimisation study.

The results of international calibration of Kerma Area Product (KAP) meters for European SENTINEL survey on patient dose optimisation of cardiac and interventional radiology practice are presented. Twelve countries were involved in the study. An investigation was conduced on 25 KAP meters fitted to undercouch X-ray tubes; 13 KAP meters were installed on cardiac units and the remaining 12 on interventional ones. The simplified calibration method has been applied, consisting of KAP estimation by multiplying the air kerma at the centre of the X-ray field by the irradiated area. The obtained values of calibration factors range from 0.4 to 0.9 and from 0.4 to 0.8 for KAP meters installed on cardiac and interventional units, respectively. They account also for table and mattress attenuation. For air kerma assessment, measurements with thermoluminescent dosemeters have been applied and when possible compared against an additional reference dosemeter. As the result of the investigation, the importance of calibration of KAP meters in clinical conditions that include mattress and table attenuation has been recognised.

Application of European protocol in the evaluation of contrast-to-noise ratio and mean glandular dose for two digital mammography systems.

The performance of two digital mammography systems, Agfa CR75 and CRMM3 computed radiography (CR) and IMS Giotto MD direct digital radiography (DR), was assessed by applying a method recommended in the European protocol for quality control in mammography screening. The contrast-to-noise ratio (CNR) and mean glandular dose (MGD) values were measured and contrast detail (CD) analysis was performed. The CNRs for system CR were 21.9, 12.9, 9.5, 8.8, 7.4, 5.5 and 4.4 for 2, 3, 4, 4.5, 5, 6 and 7-cm polymenthylmethacrylate (PMMA) thickness, respectively. The respective CNRs for system DR were 10.4, 8.8, 6.3, 7.3, 7.2, 6.4 and 6.54. For the same phantom thickness sequence, the MGDs were 0.7, 1.1, 1.3, 1.6, 1.9, 2.5 and 3.4 mGy for system CR, whereas they were 0.7, 1.2, 1.1, 1.3, 1.8, 3.5 and 3.9 mGy for system DR. The CNR and MGD results satisfactorily correlate with CD analysis results. The MGD values compare well with the values recommended in the European protocol. Despite being simple, CNR and MGD can provide an effective system for performance assessment and constancy checks for related optimisations.

The SENTINEL project.

Health-care expenditure on radiological equipment in Europe is a growing fraction of the gross domestic product for all member states. This increase in expenditure has been driven by technical developments in equipment design, matched by the introduction of novel clinical practices, examinations and procedures. The radiation protection implications of these developments have to be assessed. The SENTINEL co-ordination action covered radiation protection, safety and related issues that arise from these technical and clinical developments. SENTINEL covered 90% of patient examinations in European Radiology, 60% of the collective dose from medical sources and approximately 50% of the collective dose to European citizens from man-made sources. The SENTINEL co-ordination actions 'main' objective was to address the safety and efficacy issues which are common to all digital diagnostic imaging systems, including nuclear medicine. High-dose procedures and sensitive groups (such as children) were covered by the project. Specifically, the co-ordination action aimed: (1) to establish both physical and clinical image quality criteria and link the two, (2) to undertake a series of dosimetry studies to establish the reference levels for new procedures and (3) to develop good practice guidelines for radiation protection in digital imaging and produce training material.

Count-rate analysis from clinical scans in PET with LSO detectors.

The purpose of optimising the acquisition parameters in positron emission tomography is to improve the quality of the diagnostic images. Optimisation can be done by maximising the noise equivalent count rate (NECR) that in turn depends on the coincidence rate. For each bed position the scanner records coincidences and singles rates. For each patient, the true, random and scattered coincidences as functions of the single count rate(s) are determined by fitting the NEMA (National Electrical Manufacturers Association) 70 cm phantom count rate curves to measured clinical points. This enables analytical calculation of the personalised PNECR [pseudo NECR(s)] curve, linked to the NECR curve. For central bed positions, missing activity of approximately 70% is estimated to get maximum PNECR (PNECR(max)), but the improvement in terms of signal-toz-noise ratio would be approximately 15%. The correlation between patient weight and PNECR(max) is also estimated to determine the optimal scan duration of a single bed position as a function of patient weight at the same PNEC. Normalising the counts at PNECR(max) for the 70 kg patient, the bed duration for a 90 kg patient should be 230 s, which is approximately 30% longer. Although the analysis indicates that the fast scanner electronics allow using higher administered activities, this would involve poor improvement in terms of NECR. Instead, attending to higher bed duration for heavier patients may be more useful.

Commissioning and constancy protocols for digital angiographic units.

During the European Concerted Action SENTINEL 'Safety and Efficacy for New Techniques and Imaging using New Equipment to Support European Legislation', protocols for commissioning and constancy tests for dynamic digital flat detectors angiography units have been developed in order to harmonise practice among the European counties. The commissioning protocol includes measurements on X-ray tube and generator, patient and detector radiation dose and image quality. The constancy protocol is based on the dose and image quality measurements. The commissioning protocol was tested by SENTINEL partners who expressed an interest in checking their dynamic digital systems using this protocol. The results of basic tests are reported.

Quality criteria for cardiac images: an update.

The DIMOND II and III Cardiology Groups have agreed on quality criteria for cardiac images and developed a scoring system, to provide a tool to test quality of coronary angiograms, which was demonstrated to be of value in clinical practice. In the last years, digital flat panel technology has been introduced in cardiac angiographic systems and the radiological technique may have been influenced by the better performance of these new detectors. This advance in digital imaging, together with the lesson learned from previous studies, warranted the revision of the quality criteria for cardiac angiographic images as formerly defined. DIMOND criteria were reassessed to allow a simpler evaluation of angiograms. Clinical criteria were simplified and separated from technical criteria. Furthermore, the characteristics of an optimised angiographic technique have been outlined.

Proposal for a patient database on cardiac interventional exposures for epidemiological studies.

Relatively high organ doses absorbed by patients in interventional cardiology suggest the opportunity to define these patients as a cohort to be followed forward in time in an epidemiological study of the cancer risks associated with exposure to low-dose ionising radiation. In this paper, the UNSCEAR 2000 Report risk estimates for the most exposed organs/tissues in cardiac interventional procedures are reviewed, as well as the critical features of such an epidemiological study that is anticipated to have an intrinsically low statistical power because of the low levels of risk and possible confounding factors. To overcome these limitations, data collected in different institutions can be combined provided that a common design and conduct are used for dose assessment. A minimum dataset to be collected on a patient basis is proposed that can be implemented routinely in most facilities. This data should be linked to the local patient information system in order to retrieve all the exposures of a given patient.

Reference levels at European level for cardiac interventional procedures.

In interventional cardiology, a wide variation in patient dose for the same type of procedure has been recognised by different studies. Variation is almost due to procedure complexity, equipment performance, procedure protocol and operator skill. The SENTINEL consortium has performed a survey in nine european centres collecting information on near 2000 procedures, and a new set of reference levels (RLs) for coronary angiography and angioplasty and diagnostic electrophysiology has been assessed for air kerma-area product: 45, 85 and 35 Gy cm2, effective dose: 8, 15 and 6 mSv, cumulative dose at interventional reference point: 650 and 1500 mGy, fluoroscopy time: 6.5, 15.5 and 21 min and cine frames: 700 and 1000 images, respectively. Because equipment performance and set-up are the factors contributing to patient dose variability, entrance surface air kerma for fluoroscopy, 13 mGy min(-1), and image acquisition, 0.10 mGy per frame, have also been proposed in the set of RLs.

Survey on performance assessment of cardiac angiography systems.

Advances in imaging technology have facilitated the development of increasingly complex interventional cardiac equipment. Consequently, there is a need for definitive equipment requirements. The aim of the study is to assess the performances of different cardiac angiographic systems. A questionnaire was sent to centres participating in SENTINEL Project to collect dosimetry data (typical entrance dose rate in fluoroscopy and imaging mode), image quality evaluations (low and high contrast resolutions) and KAP calibration factors. Results from this survey could contribute to the explanation of patient dose variability in angiographic cardiac procedures and to derive reference levels for cardiac angiographic equipment performance parameters.

Staff dosimetry in interventional cardiology: survey on methods and level of exposure.

In interventional cardiac procedures, staff operates near the patient in a non-uniformly scattered radiation field. Consequently, workers may receive, over a period, relatively high radiation doses. The measurement of individual doses to personnel becomes critical due to the use of protective devices and, as a consequence of the large number of methods proposed to assess the effective dose, great variability in monitoring programmes is expected among European countries. SENTINEL consortium has conducted a survey on staff dosimetry methods and on the level of staff exposure in 12 European cardiac centres demonstrating the urgent need to harmonise dosimetry methods. From the dosimetry survey, constraint annual effective dose of 1.4 mSv and Hp(0.07) over the protective apron of 14 mSv are proposed for the optimisation the exposure the most-exposed operator.

Patient dose in interventional radiology: a European survey.

Patient doses for a few common fluoroscopy-guided procedures in interventional radiology (IR) (excluding cardiology) were collected from a few radiological departments in 13 European countries. The major aim was to evaluate patient doses for the basis of the reference levels. In total, data for 20 procedures for about 1300 patients were collected. There were many-fold variations in the number of IR equipment and procedures per population, in the entrance dose rates, and in the patient dose data (total dose area product or DAP, fluoroscopy time and number of frames). There was no clear correlation between the total DAP and entrance dose rate, or between the total DAP and fluoroscopy time, indicating that a number of parameters affect the differences. Because of the limited number of patients, preliminary reference levels were proposed only for a few procedures. There is a need to improve the optimisation of IR procedures and their definitions and grouping, in order to account for their different complexities.

ICRP Publication 139: Occupational Radiological Protection in Interventional Procedures.

Abstract: In recent publications, such as Publications 117 and 120, the Commission provided practical advice for physicians and other healthcare personnel on measures to protect their patients and themselves during interventional procedures. These measures can only be effective if they are encompassed by a framework of radiological protection elements, and by the availability of professionals with responsibilities in radiological protection. This framework includes a radiological protection programme with a strategy for exposure monitoring, protective garments, education and training, and quality assurance of the programme implementation. Professionals with responsibilities in occupational radiological protection for interventional procedures include: medical physicists; radiological protection specialists; personnel working in dosimetry services; clinical applications support personnel from the suppliers and maintenance companies; staff engaged in training, standardisation of equipment, and procedures; staff responsible for occupational health; hospital administrators responsible for providing financial support; and professional bodies and regulators. This publication addresses these elements and these audiences, and provides advice on specific issues, such as assessment of effective dose from dosimeter readings when an apron is worn, estimation of exposure of the lens of the eye (with and without protective eyewear), extremity monitoring, selection and testing of protective garments, and auditing the interventional procedures when occupational doses are unusually high or low (the latter meaning that the dosimeter may not have been worn).

Radiation-Induced Lens Opacities among Interventional Cardiologists: Retrospective Assessment of Cumulative Eye Lens Doses.

This study describes the retrospective lens dose calculation methods developed and applied within the European epidemiological study on radiation-induced lens opacities among interventional cardiologists. While one approach focuses on self-reported data regarding working practice in combination with available procedure-specific eye lens dose values, the second approach focuses on the conversion of the individual whole-body dose to eye lens dose. In contrast with usual dose reconstruction methods within an epidemiological study, a protocol is applied resulting in an individual distribution of possible cumulative lens doses for each recruited cardiologist, rather than a single dose estimate. In this way, the uncertainty in the dose estimate (from measurement uncertainty and variability among cardiologists) is represented for each individual. Eye lens dose and whole-body dose measurements have been performed in clinical practice to validate both methods, and it was concluded that both produce acceptable results in the framework of a dose-risk evaluation study. Optimal results were obtained for the dose to the left eye using procedure-specific lens dose data in combination with information collected on working practice. This method has been applied to 421 interventional cardiologists resulting in a median cumulative eye lens dose of 15.1 cSv for the left eye and 11.4 cSv for the right eye. From the individual cumulative eye lens dose distributions obtained for each cardiologist, maxima up to 9-10 Sv were observed, although with low probability. Since whole-body dose values above the lead apron are available for only a small fraction of the cohort and in many cases not for the entire working career, the second method has only been used to benchmark the results from the first approach. This study succeeded in improving the retrospective calculation of cumulative eye lens doses in the framework of radiation-induced risk assessment of lens opacities, but it remains dependent on self-reported information, which is not always reliable for early years. However, the calculation tools developed can also be used to make an assessment of the eye lens dose in current practice.

ICRP Publication 135: Diagnostic Reference Levels in Medical Imaging.

Abstract ­: The International Commission on Radiological Protection (ICRP) first introduced the term 'diagnostic reference level' (DRL) in 1996 in Publication 73. The concept was subsequently developed further, and practical guidance was provided in 2001. The DRL has been proven to be an effective tool that aids in optimisation of protection in the medical exposure of patients for diagnostic and interventional procedures. However, with time, it has become evident that additional advice is needed. There are issues related to definitions of the terms used in previous guidance, determination of the values for DRLs, the appropriate interval for re-evaluating and updating these values, appropriate use of DRLs in clinical practice, methods for practical application of DRLs, and application of the DRL concept to newer imaging technologies. This publication is intended as a further source of information and guidance on these issues. Some terminology has been clarified. In addition, this publication recommends quantities for use as DRLs for various imaging modalities, and provides information on the use of DRLs for interventional procedures and in paediatric imaging. It suggests modifications in the conduct of DRL surveys that take advantage of automated reporting of radiation-dose-related quantities, and highlights the importance of including information on DRLs in training programmes for healthcare workers. The target audience for this publication is national, regional, and local authorities; professional societies; and facilities that use ionising radiation for medical purposes, and responsible staff within these facilities. A full set of the Commission's recommendations is provided.

Patient dosimetry approaches in interventional cardiology and literature dose data review.

Interventional radiology contributes a significant proportion of the collective dose of the population from medical exposures. Interventional radiology procedures are usually fluoroscopy-guided diagnostic and therapeutic interventions. When complex procedures are performed or procedures are repeated for the same patient, high-radiation dose levels can occur because procedures often require long fluoroscopy times and require high-quality images. For all of these reasons, dosimetric evaluations in interventional radiology are widely increasing. Patient dosimetry methods currently used in interventional radiology may be divided into three categories according to dosimetry purpose: (I) dosimetry for stochastic risk evaluation, (II) dosimetry for quality assurance and (III) dosimetry to prevent the deterministic effects of radiation. A short description of dosimetric methods used in interventional cardiology practice and relevant published dosimetric data are reported.