An audit of the polytrauma fracture detection rate of clinicians evaluating lodox statscan bodygrams in two South African public sector trauma units.

BACKGROUND: Increasing global demand for specialized radiological investigations has resulted in delayed or non-reporting of plain trauma radiographs by radiologists. This is particularly true in resource-limited environments, where referring clinicians rely largely on their own radiographic interpretation. A wide accuracy range has been documented for non-radiologist reporting of conventional trauma radiographs. The Lodox Statscan whole-body digital X-ray machine is a relatively new technology that poses unique interpretive challenges. The fracture detection rate of trauma clinicians utilizing this modality has not been determined. OBJECTIVE: An audit of the polytrauma fracture detection rate of clinicians evaluating Lodox Statscan bodygrams in two South African public-sector Trauma Units. METHODS: A retrospective descriptive study of imaging data of Cape Town Level 1-equivalent public-sector Trauma Units during March-April 2015. Statscan bodygrams acquired for adult polytrauma triage were reviewed and correlated with follow-up imaging and patient records. Missed fractures were stratified by body part, mechanism of injury and ventilatory support. The fracture detection rate was determined with 95% confidence. The Generalised Fischer Exact Test assessed any association between the fracture site and failure of detection. Specialist orthopaedic review assessed the potential need for surgical management of missed fractures. RESULTS: 227 patients (male = 193, 85%; mean age: 33 years) were included; 195 fractures were demonstrated on the whole-body triage projections. Lower limb fractures predominated (n = 66, 34%). The fracture detection rate was 89% (95% CI = 86-93%), with the site of fracture associated with failure of detection (p = 0.01). Twelve of 21 undetected fractures (57%) involved the elbow or shoulder girdle. All elbow fractures (n = 3, 100%), more than half the shoulder girdle fractures (9/13,69%) and 12% (15/123) of extremity fractures were undetected. One missed fracture (1/21,4.7%) unequivocally required surgical management, while a further 7 (7/21, 33.3%) could potentially have benefitted from surgery, depending on follow-up imaging findings. CONCLUSION: This is the first analysis of the accuracy of bodygram polytrauma fracture detection by clinicians. Particular review of the shoulder girdle, elbow and extremities for subtle fractures, in addition to standardized limb positioning, are recommended for improved diagnostic accuracy in this setting. These findings can inform clinician training courses in this domain.

Development of a remote purification apparatus with disposable evaporator for the routine production of high-quality 64Cu for clinical use.

We developed a new apparatus for the routine production of 64Cu in clinical use. The apparatus has many disposable parts that stabilize the product quality (such that there is a low deviation of the concentrations of impurity metals in the product) and reduce the work load of preparation for routine production. We also developed a new evaporator using near-infrared heaters for disposable use. We conducted a production test using the new apparatus and evaluated product quality. The product yield was 6.3 ±â€¯0.32 GBq (end of bombardment) (N = 4), the product quality in terms of the concentrations of impurity metals (Cu2+, Ni2+, Fe3+, Zn2+, Mn2+) was as good as that usually achieved, likely on the order of parts per billion, and the preparation time was reduced from 2 days to 1 day.

In-house cyclotron production of high-purity Tc-99m and Tc-99m radiopharmaceuticals.

In the last years, the technology for producing the important medical radionuclide technetium-99m by cyclotrons has become sufficiently mature to justify its introduction as an alternative source of the starting precursor [99mTc][TcO4]- ubiquitously employed for the production of 99mTc-radiopharmaceuticals in hospitals. These technologies make use almost exclusively of the nuclear reaction 100Mo(p,2n)99mTc that allows direct production of Tc-99m. In this study, it is conjectured that this alternative production route will not replace the current supply chain based on the distribution of 99Mo/99mTc generators, but could become a convenient emergency source of Tc-99m only for in-house hospitals equipped with a conventional, low-energy, medical cyclotron. On this ground, an outline of the essential steps that should be implemented for setting up a hospital radiopharmacy aimed at the occasional production of Tc-99m by a small cyclotron is discussed. These include (1) target production, (2) irradiation conditions, (3) separation/purification procedures, (4) terminal sterilization, (5) quality control, and (6) Mo-100 recovery. To address these issues, a comprehensive technology for cyclotron-production of Tc-99m, developed at the Legnaro National Laboratories of the Italian National Institute of Nuclear Physics (LNL-INFN), will be used as a reference example.

Radiosynthesis and modified quality control of O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) for brain tumor imaging.

O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) is the most promising radio-labeled amino acid tracer for brain tumor imaging due to the limitation of 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG) and L-methyl-[11C]methionine (11C-MET). However, it has some limitations in radiosynthesis and related quality control that make it less frequently used in many PET centers, in this study, we report a new modification of [18F]FET production using a commercially available fully automated GRP SCINTOMICS module overcoming some of the existing limitations along with a suggestion of a simplified quality control procedure with special focus placed on enantiomeric and radiochemical purity. ([18F]FET) was produced in high radiochemical and enantiomeric purity more than 99% and non-decay corrected yield 25±5% in about 55min.

Basic Study on Visibility and Water Equivalency of a New Colorless Transparent Bolus for Electron Radiotherapy.

Boluses used in electron radiotherapy need to have radiation field visibility and water equivalence. In this report, we have examined field visibility and water equivalence of a new colorless transparent bolus. We examined field visibility, water equivalence, and dose profile. Field visibility was evaluated by comparison to conventional bolus. Water equivalence was investigated by a measured fluence scaling factor. The dose profile was measured by using radiochromic film with the bolus and an ionization chamber in water. We confirmed that the irradiation field could clearly be seen through the transparent colorless bolus. The bolus did not cast a field edge as compared with the conventional bolus. The fluence scaling factor was less than 0.8% as compared to water. We confirmed that the colorless transparent bolus was treated as a water equivalent material. The percentage depth dose (PDD) measured by using radiochromic film with the bolus matched the PDD measured with an ionization chamber in water. R50 was less than 1 mm as compared to PDD measured with an ionization chamber. It was confirmed that the colorless transparent bolus can use to set up patient without losing visibility on flat ground planes. The fluence scaling factor and dose profile measured by using the bolus matched the results measured in water. Therefore, the new colorless transparent bolus has feasibility to improve patient setup efficiency and can improve calculation accuracy by using the fluence scaling factor.

Efficient automated synthesis of 2-(5-[18F]fluoropentyl)-2-methylmalonic acid ([18F]ML-10) on a commercial available [18F]FDG synthesis module.

[18F]ML-10 (2-(5-[18F]fluoro-pentyl)-2-methylmalonic acid) is a small molecule positron emission tomography (PET) probe for apoptosis imaging. Automated synthesis of [18F]ML-10 was developed by using two different purification methods through a direct saponification procedure on a modified commercial [18F]Fluoro-2-Deoxyglucose ([18F]FDG) synthesizer. C18 purification method 1: The final [18F]ML-10 solution containing ethanol was obtained with radiochemical yields of 60±5% (n=5) at the end of bombardment (EOB) and radiochemical purity of 98% in 35min. Al2O3 and SCX purification method 2: To avoid possible side effects of a conventional ethanol-containing formulation, an new ethanol-free solution of [18F]ML-10 was also developed, the radiochemical yields was 50±5% (n=5, EOB) within 45min and the radiochemical purity was 98%.

Comparison of Analytical Values in Diffusion Kurtosis Imaging among Different MRI Units.

Diffusion kurtosis imaging (DKI) is a method of analyzing restricted diffusion. Mean kurtosis (MK) is obtained from DKI. It is not known how different MRI scanners and coil systems will change MK when the same imaging parameters are used. The purpose of this study is to identify tendencies in MK when using various MRI scanners and coil systems. A total of 27 healthy volunteers were enrolled in this study. DKI was performed on the brain for each volunteer on five MRI scanner/coil system combinations using the same scan parameters. MK of 10 anatomical areas of the brain were compared, and the signal-noise ratios (SNRs) of b-2000 s/mm2 images were measured in identical areas. There were no significant differences among MKs from multi transmit (MT) MRI systems, but MK was significantly lower on the single transmit MRI system because of pepper artifact caused by low SNR. In conclusion, we found no significant differences in MK among MT systems, and MK was significantly lower without MT.

Fundamental Study of Three-dimensional Fast Spin-echo Imaging with Spoiled Equilibrium Pulse.

Three-dimensional fast spin-echo (3D FSE) imaging with variable refocusing flip angle has been recently applied to pre- or post-enhanced T1-weighted imaging. To reduce the acquisition time, this sequence requires higher echo train length (ETL), which potentially causes decreased T1 contrast. Spoiled equilibrium (SpE) pulse consists of a resonant +90° radiofrequency (RF) pulse and is applied at the end of the echo train. This +90° RF pulse brings residual transverse magnetization to the negative longitudinal axis, which makes it possible to increase T1 contrast. The purpose of our present study was to examine factors that influence the effect of spoiled equilibrium pulse and the relationship between T1 contrast improvement and imaging parameters and to understand the characteristics of spoiled equilibrium pulse. Phantom studies were conducted using an magnetic resonance imaging (MRI) phantom made of polyvinyl alcohol gel. To evaluate the effect of spoiled equilibrium pulse with changes in repetition time (TR), ETL, and refocusing flip angle, we measured the signal-to-noise ratio and contrast-to-noise ratio (CNR). The effect of spoiled equilibrium pulse was evaluated by calculating the enhancement rate of CNR. The factors that influence the effect of spoiled equilibrium pulse are TR, ETL, and relaxation time of tissues. Spoiled equilibrium pulse is effective with increasing TR and decreasing ETL. The shorter the T1 value, the better the spoiled equilibrium pulse functions. However, for tissues in which the T1 value is long (>600 ms), at a TR of 600 ms, improvement in T1 contrast by applying spoiled equilibrium pulse cannot be expected.

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015.

PURPOSE: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices. METHODS AND MATERIALS: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. RESULTS: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). CONCLUSIONS: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer-user training may help mitigate these events.

Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization. Final order.

The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the rectal balloon for prostate immobilization's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Decontamination of the Activation Product Based on a Legal Revision of the Cyclotron Vault Room on the Non-self-shield Compact Medical Cyclotron.

The non-self-shield compact medical cyclotron and the cyclotron vault room were in operation for 27 years. They have now been decommissioned. We efficiently implemented a technique to identify an activation product in the cyclotron vault room. Firstly, the distribution of radioactive concentrations in the concrete of the cyclotron vault room was estimated by calculation from the record of the cyclotron operation. Secondly, the comparison of calculated results with an actual measurement was performed using a NaI scintillation survey meter and a high-purity germanium detector. The calculated values were overestimated as compared to the values measured using the NaI scintillation survey meter and the high-purity germanium detector. However, it could limit the decontamination area. By simulating the activation range, we were able to minimize the concrete core sampling. Finally, the appropriate range of radioactivated area in the cyclotron vault room was decontaminated based on the results of the calculation. After decontamination, the radioactive concentration was below the detection limit value in all areas inside the cyclotron vault room. By these procedures, the decommissioning process of the cyclotron vault room was more efficiently performed.

Evaluation of Size Correction Factor for Size-specific Dose Estimates (SSDE) Calculation.

American Association of Physicists in Medicine (AAPM) Report No.204 recommends the size-specific dose estimates (SSDE), wherein SSDE=computed tomography dose index-volume (CTDIvol )×size correction factor (SCF), as an index of the CT dose to consider patient thickness. However, the study on SSDE has not been made yet for area detector CT (ADCT) device such as a 320-row CT scanner. The purpose of this study was to evaluate the SCF values for ADCT by means of a simulation technique to look into the differences in SCF values due to beam width. In the simulation, to construct the geometry of the Aquilion ONE X-ray CT system (120 kV), the dose ratio and the effective energies were measured in the cone angle and fan angle directions, and these were incorporated into the simulation code, Electron Gamma Shower Ver.5 (EGS5). By changing the thickness of a PMMA phantom from 8 cm to 40 cm, CTDIvol and SCF were determined. The SCF values for the beam widths in conventional and volume scans were calculated. The differences among the SCF values of conventional, volume scans, and AAPM were up to 23.0%. However, when SCF values were normalized in a phantom of 16 cm diameter, the error tended to decrease for the cases of thin body thickness, such as those of children. It was concluded that even if beam width and device are different, the SCF values recommended by AAPM are useful in clinical situations.