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Objectives: Recent gallium-68 labeled peptides are of increasing interest in PET imaging in nuclear medicine. Somakit TOC® is a radiopharmaceutical kit registered in the European Union for the preparation of [68Ga]Ga-DOTA-TOC used for the diagnosis of neuroendocrine tumors. Development of a labeling process using a synthesizer is particularly interesting for the quality and reproducibility of the final product although only manual processes are described in the Summary of Product (SmPC) of the registered product. The aim of the present study was therefore to evaluate the feasibility and value of using an automated synthesizer for the preparation of [68Ga]Ga-DOTA-TOC according to the SmPC of the Somakit TOC®., Methods: Three methods of preparation were compared; each followed the SmPC of the Somakit TOC®. Over time, overheads, and overexposure were evaluated for each method., Results: Mean±SD preparation time was 26.2±0.3 minutes for the manual method, 28±0.5 minutes for the semi-automated, and 40.3±0.2 minutes for the automated method. Overcost of the semi-automated method is 0.25€ per preparation for consumables and from 0.58€ to 0.92€ for personnel costs according to the operator (respectively, technician or pharmacist). For the automated method, overcost is 70€ for consumables and from 4.06€ to 6.44€ for personnel. For the manual method, extremity exposure was 0.425mSv for the right finger, and 0.350mSv for the left finger; for both the semi-automated and automated method extremity exposure were below the limit of quantification., Conclusion: The present study reports for the first time both the feasibility of using a [68Ga]- radiopharmaceutical kit with a synthesizer and the limits for the development of a fully automated process., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Fractionated elution consists in collecting the fractions of an eluate with the highest radioactive concentration. It may be useful to meet the requirements of a subset of clinical radiopharmacy procedures. This study aims to describe and evaluate straightforward procedures allowing to readily perform fractionated elution on dry and wet columns Mo/Tc generators by using calibrated vials. The main objectives of this study consisted in determining the relationship between eluate volume and elution yield using different vials calibration and assessing repeatability of the procedure. Elution vials were calibrated to obtain different eluate volumes by addition of air for wet column generator (WCG) and subtraction of saline for dry column generator (DCG) (n≥5 for each calibration). The relationship between the eluate volume and the elution yield was determined by a regression model for both DCG and WCG. Then repeatability evaluation was performed using 3-ml vial calibration. Relationships between the eluate volume (V) and the elution yield (Y) for DCG and WCG were Y=57.551 ln(V)+10.526 and Y=50.256 ln(V)+17.597, respectively. For repeatability assessment (n=30 for DCG and n=31 for WCG), the median volume and the interquartile range for DCG and WCG were 2.98 ml (2.92-3.01) and 3.28 ml (2.71-3.40), respectively, and median (interquartile range) eluate yields were 84.73% (81.30-86.33) and 81.78% (78.91-85.20), respectively. The volume was significantly higher for WCG than DCG (P=0.036) and also significantly more variable (P<0.001). The elution yield was significantly lower for WCG than DCG (P=0.025), but no difference in variability between the two generators was found (P=0.874). Easy-to-handle fractionated elution methods are compatible with both DCG and WCG. Fractionation using calibrated vials exhibits a better reproducibility with DCG than WCG generators and represents the only proposed method so far to master fractionated elution with DCG.

Increased costs cannot be exclusively attributed to the consequences of insulin prescription. Any initiative designed to&#160;accelerate acquisition of patient autonomy would be likely to reduce the costs observed after switching to insulin, provided this initiative is adapted to the patient&#8217;s health profile, diabetes history and available medical resources..

The aim of this study was to describe and evaluate an approach for improving radiopharmaceutical supply chain safety by implementing bar code technology. We first evaluated the current situation of our radiopharmaceutical supply chain and, by means of the ALARM protocol, analysed two dispensing errors that occurred in our department. Thereafter, we implemented a bar code system to secure selected key stages of the radiopharmaceutical supply chain. Finally, we evaluated the cost of this implementation, from overtime, to overheads, to additional radiation exposure to workers. An analysis of the events that occurred revealed a lack of identification of prepared or dispensed drugs. Moreover, the evaluation of the current radiopharmaceutical supply chain showed that the dispensation and injection steps needed to be further secured. The bar code system was used to reinforce product identification at three selected key stages: at usable stock entry; at preparation-dispensation; and during administration, allowing to check conformity between the labelling of the delivered product (identity and activity) and the prescription. The extra time needed for all these steps had no impact on the number and successful conduct of examinations. The investment cost was reduced (2600 euros for new material and 30 euros a year for additional supplies) because of pre-existing computing equipment. With regard to the radiation exposure to workers there was an insignificant overexposure for hands with this new organization because of the labelling and scanning processes of radiolabelled preparation vials. Implementation of bar code technology is now an essential part of a global securing approach towards optimum patient management.

Background: Patients are at risk of drug-related problems (DRPs) at transition points during hospitalization. The community pharmacist (CP) is often the first healthcare professional patients visit after discharge. CPs lack sufficient information about the patient and so they may be unable to identify problems in medications, which may lead to dispensing the wrong drugs or dosage, and/or giving wrong information. We aim to assess the impact of a complex intervention comprising of medication reconciliation performed at discharge by a hospital pharmacist (HP) with communication between the HP and CP on DRPs during the seven days following discharge., Methods/design: The study is a cluster randomized crossover trial involving 46 care units (each unit corresponding to a cluster) in 22 French hospitals during two consecutive 14-day periods, randomly assigned as 'experimental' or 'control' (usual care) periods. We will recruit patients older than 18 years of age and visiting the same CP for at least three months. We will exclude patients with a hospital length of stay of more than 21 days, who do not return home or those in palliative care. During the experimental period, the HP will perform a medications reconciliation that will be communicated to the patient. The HP will inform the patient's CP about the patient's drug therapy (modification in home medication, acute drugs prescribed, nonprescription treatments, and/or lab results). The primary outcome will be a composite outcome of any kind of drug misuse during the seven days following discharge assessed at day seven (±2) post-discharge by a pharmacist in charge of the study who will contact both patients and CPs by phone. The secondary outcome will be unplanned hospitalizations assessed by phone contact at day 35 (±5) after discharge. We plan to recruit 1,176 patients., Discussion: This study will assess the impact of a reconciliation of medications performed at patient discharge followed by communication between the HP and the patient's CP. It will allow for identifying the type of patients in France for which the intervention is most relevant., Trial Registration: This study was registered with ClinicalTrials.gov (number: NCT02006797) on 5 December 2013.

Terrestrial inputs (natural and anthropogenic) from rivers, the atmosphere and physical processes strongly impact the functioning of coastal pelagic ecosystems. The objective of this study was to develop a tool for the examination of these impacts on the Marseille coastal area, which experiences inputs from the Rhone River and high rates of atmospheric deposition. Therefore, a new 3D coupled physical/biogeochemical model was developed. Two versions of the biogeochemical model were tested, one model considering only the carbon (C) and nitrogen (N) cycles and a second model that also considers the phosphorus (P) cycle. Realistic simulations were performed for a period of 5 years (2007-2011). The model accuracy assessment showed that both versions of the model were able of capturing the seasonal changes and spatial characteristics of the ecosystem. The model also reproduced upwelling events and the intrusion of Rhone River water into the Bay of Marseille well. Those processes appeared to greatly impact this coastal oligotrophic area because they induced strong increases in chlorophyll-a concentrations in the surface layer. The model with the C, N and P cycles better reproduced the chlorophyll-a concentrations at the surface than did the model without the P cycle, especially for the Rhone River water. Nevertheless, the chlorophyll-a concentrations at depth were better represented by the model without the P cycle. Therefore, the complexity of the biogeochemical model introduced errors into the model results, but it also improved model results during specific events. Finally, this study suggested that in coastal oligotrophic areas, improvements in the description and quantification of the hydrodynamics and the terrestrial inputs should be preferred over increasing the complexity of the biogeochemical model.

In France, radiopharmaceuticals preparation and dispensation are made under the responsibility of a pharmacist. This last one made a pharmaceutical over-specialization in the field of the medical use of radioelements. However, a flaw in the French law allows nuclear medicine units to avoid the presence of the radiopharmacist decreasing so the quality and the safety of the care brought to patients. This article aims at looking for legal solutions to maintain these quality and safety by the empowerment of the radiopharmacist statute while taking into account economic aspects., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

(99m)Tc-macroaggregated albumin is widely used to diagnose pulmonary embolism. To control the radiochemical purity of this radiopharmaceutical, three rapid control methods using filter, thin layer chromatography or centrifugation, are described in the academic literature. In this paper, the interactions between impurities and (99m)Tc-macroaggregated albumin were presented. For each control method, the influence of these interactions on the determination of the radiochemical purity of labeled macroaggregated albumin was evaluated. Then, a comparison of radiochemical purity obtained by these three methods was performed in normal condition and with different addition of pertechnetate. Finally, a correlation between these three methods was investigated. The results show a specificity difference between these three control methods. However in practice, this difference has no impact on the evaluation of the radiochemical purity of (99m)Tc-macroaggregated albumin by these three methods. In additions, methods are still correlated with pertechnetate additions in (99m)Tc-macroaggregated albumin suspension. Thus, this study demonstrates that these three control methods are exchangeable in radiopharmacy.

In the perspective of expanding the use of annexin A5 (anx A5) as radioactive tracer of cell death in vivo, we recently described its radiolabeling with (99m)Tc-tricarbonyl [(99m)Tc(H(2)O)(3)(CO)(3)](+) via the mercaptobutyrimidyl group (anx A5-SH). The aim of the present article was to compare this new method with the HYNIC strategy (anx A5-HYNIC), recognized at present as the reference for the radiolabeling of proteins with (99m)Tc. Similar radiolabeling yields and better chemical stability were obtained with the [anx A5-SH-(99m)Tc-tricarbonyl] complex. Since the [anx A5-HYNIC-(99m)Tc(tricine)(2)] conjugate shows isomeric forms which can affect the biological properties whereas [anx A5-SH-(99m)Tc-tricarbonyl] is less or not prone to such drawback, the latter seems superior to the former. Furthermore, (anx A5-SH) is readily obtained via commercial sources of Traut's reagent whereas (anx A5-HYNIC) is not. The results provide encouraging evidence in the development of anx A5-labeled reagent for apoptose imaging.

Vertigo and dizziness are the most common complications of cochlear implantation. Data of a multicentric study about clinical aspects and cost utility were collected for vertigo and dizziness: incidence, clinical and treatment were analyzed among 469 adults and children. Results demonstrated that 16% of adults and 3% of children experienced dizziness postoperatively. In a few cases a specific mechanism as perilymphatic fistula was identified. In other cases the mechanism underlying delayed vertigo remains speculative and endolymphatic hydrops was suggested.

Twelve patients underwent microvascular decompression by retrosigmoid approach to relieve severe hemifacial spasm. The surgery was done under intraoperative monitoring of the auditory function. Assessment at Day 2, Day 10, 2 months and 6 months after the operation found that the surgery had resulted in 9 recoveries, 3 improvements and 1 failure. Brain stem auditory evoked potentials monitoring showed that the interposition of Teflon between the vascular loop and the facial nerve is a critical stage for the auditory function. Six of the twelve patients were also complaining of cochleo-vestibular disorders: vertigo and tinnitus, or hearing loss and tinnitus, or vertigo alone. The surgery improved at least one of these cochleo-vestibular symptoms in each one of the patients. There was one hearing improvement, vertigo disappeared in three cases out of four, and tinnitus disappeared in four cases out of five. The possibility of a concomitant compression of cochleo-vestibular and facial nerve was investigated using cochleovestibular tests, radiological data and intra-operative findings.

We sought to determine whether the rotatory impulsional test was capable of exploring the canalar function with sufficient precision to replace the caloric test, as it has been recently affirmed. We first compared the observed preponderance from this test with that measured during a sinusoidal (20 and 4 s) test. We observed that, in the case of a significant preponderance for a given test, there was complete redondance with the preponderance observed with any other test. The rotatory impulsional test does not present any specific advantage compared to other kinetic test as far as the observation of the preponderance phenomenon. We then compared the preponderance with the results of the caloric tests and came to the following conclusions i) the absence of preponderance does not allow us to predict the absence of vestibular deficit, due to the fact that 37% of the deficits were compensated for including acoustic neuroma; ii) the presence of a preponderance does not allow a priori to say whether it is of vestibular, cervical, or central origin and systematic caloric tests shows that almost one fourth of preponderance observed is not associated with unilateral weakness iii) supposing that a clinical argument allow us to conclude as to the probable vestibular origin of a vestibular preponderance, the direction of this preponderance does not allow us to determine which side is involved. In fact, if the undercompensated deficits are 3 times more frequent than overcompensated deficits, the proportion of preponderance not linked to a significant deficit indicates that the probability of encountering a preponderance related to a specific undercompensated deficit is approximately 50%. We thus did not find in the rotatory impulsional test any specific advantage allowing us to predict the laterality of a vestibular lesion.

Early dental loss is a well-known complication of Sjögren's syndrome. Forty percent (n = 16) of 39 consecutive patients with the syndrome had early dental loss. Dental loss correlated positively with histologic grading at lip biopsy. There was no significant correlation with any other feature of Sjögren's syndrome, including saliva flow. In 11 partially edentulous or completely edentulous patients, dental loss occurred 9 years on average before the first symptom of xerostomia. Early dental loss may reflect a silent involvement of the salivary glands and suggests that changes in saliva biochemistry occur long before xerostomia.

Starting from November 1990, an international External Quality Assessment Scheme (EQAS) for immmunoassays of tumor markers has been organized. Presently, 238 laboratories from France, Germany, Italy, Japan and Spain participate in the scheme. In this report the main features of the EQAS and data processing are outlined. Results collected during the 1992-cycle allow evaluation of the state of the art of AFP, CEA, CA 19-9, CA 15-3, CA 125 and PSA immunoassays. According to their analytical performances, the 6 tumor marker immunoassays can be classified into several groups, the first including AFP and CA 15-3 for which both total variability and within-kit agreement are good. For CEA assay, performance can be considered as satisfactory even though further improvements of between-lab agreement would be welcome. For the 3 other tumor markers, the higher total variability indicates an urgent need for a better standardization by improvement of either both within-kit and between-kit agreements (CA 19-9) or between-kit agreement mainly (PSA, CA 125).

Excluding vascular involvement, vertigo due to a central vestibular syndrome reflects a median or paramedian lesion of the brain stem or the cerebellum. Recurrent attacks of vertigo usually occur with peripheral lesions. Persistent acute vertigo with peripheral destruction can reveal ischemia of the brain stem. Central positional vertigo is rare and has symptomatology that is different from that of benign positional vertigo. Persistent instability has a symptomatology that is more difficult to analyse and is usually associated with a central vestibular syndrome when it is organic. Diagnosis of a central vestibular syndrome is based on detection of well-defined clinical or electronystagmographic signs of which abnormal nystagmus is primordial. Some of them such as inferior vertical nystagmus or dissociated nystagmus can localise the site. MRI has become the diagnostic procedure which is best adapted for identifying the most frequent aetiologies such as tumors, congenital malformations and multiple sclerosis.

The auditory brainstem responses, in a series of 131 patients with surgically confirmed acoustic neuroma, are reported. Six groups have been individualized according to the value of the I-V interpeak latency, the synchronisation of the waveform shape and the need to perform an electrocochleography. If we exclude the sixteen cases of profoundly deafness, or cophosis, where ABR and ECoG don't permit the recording of waves, the electrophysiological investigations allowed to provide the diagnosis of retrocochlear lesion in 115 patients, for a rate of 98.26%. This high degree of sensitivity favorably with data reported in literature, and supports the reliability of this method for detection of acoustic neuroma. According to these results, our diagnosis workup of a patient suspected of having an acoustic neuroma, presenting normal ABR findings, is presented.

Recent studies have suggested that the renal effects of high protein intake could be mediated, at least in part, by vasopressin and/or an increase in the urinary concentrating activity. The present study investigated the influence of the level of hydration, and hence of the activity of the concentrating process, on the renal response to an acute oral protein load. Clearance studies were performed before (Control) and during three hours after a protein meal (1.5 g/kg body wt protein as cooked meat) in ten healthy volunteers. This study was performed twice at a two to three week interval under either constant low (LowH) or high (HighH) hydration. In spite of the marked difference in initial diuresis (3.1 +/- 0.3 in LowH vs. 13.9 +/- 0.7 ml/min in HighH) and urine osmolality (501 +/- 42 in LowH vs. 99 +/- 3 mOsm/kg H2O in HighH), a similar relative decrease in urine flow rate was observed following the meal in both conditions. TcH2O increased progressively by 70% in LowH whereas CH2O decreased by 40% in HighH. Plasma vasopressin showed a progressive increase with time in LowH (from 1.10 +/- 0.26 in control, to 1.98 +/- 0.35 pg/ml at the third hour after the PM, P < 0.05) but not in HighH (0.53 +/- 0.09 to 0.70 +/- 0.17 pg/ml). Glomerular filtration rate (inulin clearance) increased significantly on the second post-prandial hour under LowH but not under HighH. Excretions rates of Na, Cl, K, and urea increased after the meal, however, not to the same extent nor with the same time course in the two conditions. Significant positive correlations were observed between GFR and TcH2O, urine osmolality, or the ratio of urine-to-plasma urea concentrations in LowH. These results suggest that the protein-induced hyperfiltration is partially blunted by a high water intake, and hence is dependent, directly or indirectly, on the urine concentrating activity.

A sensitive bioluminescent enzyme immunoassay (BEIA) for the determination of human alpha-atrial natriuretic peptide was developed. The usable ranges of the standard curve extend from 10 pg to 400 pg for the one-step method and from 2.5 to 50 pg for the two-step method.

In this paper we study the phenomenon of the acoustic emissions. This study presents two cases with different auditif pathology and their clinics applications.

The finding of perception deafness in an adult patient should set off full clinical and paraclinical evaluation, as this symptom may hide two problems requiring urgent attention. The first problem concerns the diagnosis: any unilateral and progressive perceptive deafness suggests a possible acoustic neurinoma. The second problem is one of therapeutic decision, since in all patients with sudden onset deafness the prognosis depends on an early treatment. General practitioners can use simple tests that will give them some indications on the severity of the loss of hearing, but to establish the side and cause of the deficit, additional and highly specialized examinations are always needed. Medical and hearing aids are sufficient in most patients. Surgery should be reserved to very special cases and will be contemplated or not, depending on the cause of the deafness.

A bioluminescent procedure to measure noradrenaline and serotonin has been realized. The amines are oxidized by the monoamine oxidase of pig brain mitochondria. The NH3 generated in this reaction is directly measured by enzymatic reaction. The coenzyme of this last reaction is the NADH,H+ which is measured with a bioluminescent system: the FMN-oxidoreductase-luciferase. The extension to other amines is possible, it depends only of the specificity of the monoamine oxidase.