Medical imaging clinical trials unit: a professional need

Purpose To design and describe a management and control tool and the human resources needed to efficiently manage the imaging process within clinical trials for a better quality of care for the patient. Methods A unit was created to efficiently organise the participation of our Medical Imaging Department in clinical trials. This entity was defined and monitored using a customized, flexible and modular software package that provides the necessary information to execute and monitor requests (appointments, protocols, reports, complaints, billing). Various indicators of activity and professional satisfaction were parameterised. Results From 2016 to 2020, 367 trials were participated and monitored, 50% of all the hospital clinical trials. The budget of the Medical Imaging Department grew by 47% in this period. The coordination with other departments and principal investigators improved, as shown by surveys (62% fluid and 38% very fluid), with a high perception of collaboration (86%). Conclusions The implementation of a Medical Imaging Clinical Trials Unit involve identifying the tasks, personnel, organisational needs, workflow, monitoring and invoicing. The creation of this Unit has improved the control and traceability of clinical trials within the Department.Peer ReviewedPostprint (published version

Machine Learning-Based Integration of Prognostic Magnetic Resonance Imaging Biomarkers for Myometrial Invasion Stratification in Endometrial Cancer

[EN] Background: Estimation of the depth of myometrial invasion (MI) in endometrial cancer is pivotal in the preoperatively staging. Magnetic resonance (MR) reports suffer from human subjectivity. Multiparametric MR imaging radiomics and parameters may improve the diagnostic accuracy. Purpose: To discriminate between patients with MI ¿ 50% using a machine learning-based model combining texture features and descriptors from preoperatively MR images. Study Type: Retrospective. Population: One hundred forty-three women with endometrial cancer were included. The series was split into training (n = 107, 46 with MI ¿ 50%) and test (n = 36, 16 with MI ¿ 50%) cohorts. Field Strength/Sequences: Fast spin echo T2-weighted (T2W), diffusion-weighted (DW), and T1-weighted gradient echo dynamic contrast-enhanced (DCE) sequences were obtained at 1.5 or 3 T magnets. Assessment: Tumors were manually segmented slice-by-slice. Texture metrics were calculated from T2W and ADC map images. Also, the apparent diffusion coefficient (ADC), wash-in slope, wash-out slope, initial area under the curve at 60 sec and at 90 sec, initial slope, time to peak and peak amplitude maps from DCE sequences were obtained as parameters. MR diagnostic models using single-sequence features and a combination of features and parameters from the three sequences were built to estimate MI using Adaboost methods. The pathological depth of MI was used as gold standard. Statistical Test: Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, accuracy, positive predictive value, negative predictive value, precision and recall were computed to assess the Adaboost models performance. Results: The diagnostic model based on the features and parameters combination showed the best performance to depict patient with MI ¿ 50% in the test cohort (accuracy = 86.1% and AUROC = 87.1%). The rest of diagnostic models showed a worse accuracy (accuracy = 41.67%¿63.89% and AUROC = 41.43%¿63.13%). Data Conclusion: The model combining the texture features from T2W and ADC map images with the semi-quantitative parameters from DW and DCE series allow the preoperative estimation of myometrial invasion. Evidence Level: 4 Technical Efficacy: Stage 3This study received funding from the Global Investigator Initiated Research Committee (GIIRC) research program by Bracco S.p.A (2015/0724). The funders had no role in study design, data collection and analysis and preparation of the manuscript.Rodriguez Ortega, A.; Alegre, A.; Lago, V.; Carot Sierra, JM.; Ten-Esteve, A.; Montoliu, G.; Domingo, S.... (2021). Machine Learning-Based Integration of Prognostic Magnetic Resonance Imaging Biomarkers for Myometrial Invasion Stratification in Endometrial Cancer. Journal of Magnetic Resonance Imaging. 54(3):987-995. https://doi.org/10.1002/jmri.27625S98799554

Imaging Biomarkers for the Diagnosis and Prognosis of Neurodegenerative Diseases. The Example of Amyotrophic Lateral Sclerosis

The term amyotrophic lateral sclerosis (ALS) comprises a heterogeneous group of fatal neurodegenerative disorders of largely unknown etiology characterized by the upper motor neurons (UMN) and/or lower motor neurons (LMN) degeneration. The development of brain imaging biomarkers is essential to advance in the diagnosis, stratification and monitoring of ALS, both in the clinical practice and clinical trials. In this review, the characteristics of an optimal imaging biomarker and common pitfalls in biomarkers evaluation will be discussed. Moreover, the development and application of the most promising brain magnetic resonance (MR) imaging biomarkers will be reviewed. Finally, the integration of both qualitative and quantitative multimodal brain MR biomarkers in a structured report will be proposed as a support tool for ALS diagnosis and stratification

Pancreatic steatosis and iron overload increases cardiovascular risk in non-alcoholic fatty liver disease

ObjectiveTo assess the prevalence of pancreatic steatosis and iron overload in non-alcoholic fatty liver disease (NAFLD) and their correlation with liver histology severity and the risk of cardiometabolic diseases.MethodA prospective, multicenter study including NAFLD patients with biopsy and paired Magnetic Resonance Imaging (MRI) was performed. Liver biopsies were evaluated according to NASH Clinical Research Network, hepatic iron storages were scored, and digital pathology quantified the tissue proportionate areas of fat and iron. MRI-biomarkers of fat fraction (PDFF) and iron accumulation (R2*) were obtained from the liver and pancreas. Different metabolic traits were evaluated, cardiovascular disease (CVD) risk was estimated with the atherosclerotic CVD score, and the severity of iron metabolism alteration was determined by grading metabolic hiperferritinemia (MHF). Associations between CVD, histology and MRI were investigated.ResultsIn total, 324 patients were included. MRI-determined pancreatic iron overload and moderate-to severe steatosis were present in 45% and 25%, respectively. Liver and pancreatic MRI-biomarkers showed a weak correlation (r=0.32 for PDFF, r=0.17 for R2*). Pancreatic PDFF increased with hepatic histologic steatosis grades and NASH diagnosis (p<0.001). Prevalence of pancreatic steatosis and iron overload increased with the number of metabolic traits (p<0.001). Liver R2* significantly correlated with MHF (AUC=0.77 [0.72-0.82]). MRI-determined pancreatic steatosis (OR=3.15 [1.63-6.09]), and iron overload (OR=2.39 [1.32-4.37]) were independently associated with high-risk CVD. Histologic diagnosis of NASH and advanced fibrosis were also associated with high-risk CVD.ConclusionPancreatic steatosis and iron overload could be of utility in clinical decision-making and prognostication of NAFLD

Development and validation of an image biomarker to identify metabolic dysfunction associated steatohepatitis: MR-MASH score

[Background and Aims] Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) requires histology. In this study, a magnetic resonance imaging (MRI) score was developed and validated to identify MASH in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Secondarily, a screening strategy for MASH diagnosis was investigated.[Methods] This prospective multicentre study included 317 patients with biopsy-proven MASLD and contemporaneous MRI. The discovery cohort (Spain, Portugal) included 194 patients. NAFLD activity score (NAS) and fibrosis were assessed with the NASH-CRN histologic system. MASH was defined by the presence of steatosis, lobular inflammation, and ballooning, with NAS ≥4 with or without fibrosis. An MRI-based composite biomarker of Proton Density Fat Fraction and waist circumference (MR–MASH score) was developed. Findings were afterwards validated in an independent cohort (United States, Spain) with different MRI protocols.[Results] In the derivation cohort, 51% (n = 99) had MASH. The MR–MASH score identified MASH with an AUC = .88 (95% CI .83–.93) and strongly correlated with NAS (r = .69). The MRI score lower cut-off corresponded to 88% sensitivity with 86% NPV, while the upper cut-off corresponded to 92% specificity with 87% PPV. MR–MASH was validated with an AUC = .86 (95% CI .77–.92), 91% sensitivity (lower cut-off) and 87% specificity (upper cut-off). A two-step screening strategy with sequential MR–MASH examination performed in patients with indeterminate-high FIB-4 or transient elastography showed an 83–84% PPV to identify MASH. The AUC of MR–MASH was significantly higher than that of the FAST score (p < .001).[Conclusions] The MR–MASH score has clinical utility in the identification and management of patients with MASH at risk of progression.David Marti-Aguado (DMA) is the recipient of a Joan Rodés (JR22/00002) and Río Hortega award (CM19/00212), Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation). He also received an award from the University of Valencia (UV-RI_MID-1528578) to carry out a Doctorate in International Mobility Stay at the University of Pittsburgh Medical Center (Pittsburgh, PA, USA), and a grant Grupo de Investigación Emergente (CIGE/2022/37) from Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital, Generalitat Valenciana, Spain.Peer reviewe

Plataforma de segmentación de las estructuras bucodentales y predicción de implantes de carga inmediata

Esta plataforma para la planificación de implantología dental ha sido evaluada como una herramienta software de imágenes médicas, con el fin de dar soporte a la decisión del implantologo. El enfoque permite construir un modelo 3D de la estructura dental del paciente (mandíbula y dientes) desde imágenes de Tomografía Computariazada (TC) así como una evaluación de su densidad ósea. Además esta plataforma tiene la intención de evaluar la colocación del implante y diseñar un modelo STL para la futura creación de férulas las cuales proporcionan una mejor ubicación del implante y colocación en la boca.Ten Esteve, A. (2014). Plataforma de segmentación de las estructuras bucodentales y predicción de implantes de carga inmediata. http://hdl.handle.net/10251/47829.Archivo delegad

Discrete particle model for cement infiltration within open-cell structures: Prevention of osteoporotic fracture.

This paper proposes a discrete particle model based on the random-walk theory for simulating cement infiltration within open-cell structures to prevent osteoporotic proximal femur fractures. Model parameters consider the cement viscosity (high and low) and the desired direction of injection (vertical and diagonal). In vitro and in silico characterizations of augmented open-cell structures validated the computational model and quantified the improved mechanical properties (Young's modulus) of the augmented specimens. The cement injection pattern was successfully predicted in all the simulated cases. All the augmented specimens exhibited enhanced mechanical properties computationally and experimentally (maximum improvements of 237.95 ± 12.91% and 246.85 ± 35.57%, respectively). The open-cell structures with high porosity fraction showed a considerable increase in mechanical properties. Cement augmentation in low porosity fraction specimens resulted in a lesser increase in mechanical properties. The results suggest that the proposed discrete particle model is adequate for use as a femoroplasty planning framework

Quantitative magnetic resonance imaging assessment of muscle composition in myotonic dystrophy mice

Abstract Myotonic dystrophy type 1 (DM1) is a severe autosomal dominant neuromuscular disease in which the musculoskeletal system contributes substantially to overall mortality and morbidity. DM1 stems from a noncoding CTG trinucleotide repeat expansion in the DMPK gene. The human skeletal actin long repeat (HSALR) mouse model reproduces several aspects of the disease, but the muscle-wasting phenotype of this model has never been characterized in vivo. Herein, we used quantitative MRI to measure the fat and muscle volumes in the leg compartment (LC) of mice. These acquired data were processed to extract relevant parameters such as fat fraction and fat infiltration (fat LC/LC) in HSALR and control (FBV) muscles. These results showed increased fat volume (fat LC) and fat infiltration within the muscle tissue of the leg compartment (muscle LC), in agreement with necropsies, in which fatty clumps were observed, and consistent with previous findings in DM1 patients. Model mice did not reproduce the characteristic impaired fat fraction, widespread fat replacement through the muscles, or reduced muscle volume reported in patients. Taken together, the observed abnormal replacement of skeletal muscle by fat in the HSALR mice indicates that these mice partially reproduced the muscle phenotype observed in humans

A Gadolinium(III) Complex Based on the Thymine Nucleobase with Properties Suitable for Magnetic Resonance Imaging

The paramagnetic gadolinium(III) ion is used as contrast agent in magnetic resonance (MR) imaging to improve the lesion detection and characterization. It generates a signal by changing the relaxivity of protons from associated water molecules and creates a clearer physical distinction between the molecule and the surrounding tissues. New gadolinium-based contrast agents displaying larger relaxivity values and specifically targeted might provide higher resolution and better functional images. We have synthesized the gadolinium(III) complex of formula [Gd(thy)2(H2O)6](ClO4)3·2H2O (1) [thy = 5-methyl-1H-pyrimidine-2,4-dione or thymine], which is the first reported compound based on gadolinium and thymine nucleobase. 1 has been characterized through UV-vis, IR, SEM-EDAX, and single-crystal X-ray diffraction techniques, and its magnetic and relaxometric properties have been investigated by means of SQUID magnetometer and MR imaging phantom studies, respectively. On the basis of its high relaxivity values, this gadolinium(III) complex can be considered a suitable candidate for contrast-enhanced magnetic resonance imaging