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7. Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy

Author

Korenblik, R., Olij, B., Aldrighetti, L. A., Hilal, M. Abu, Ahle, M., Arslan, B., van Baardewijk, L. J., Baclija, I., Bent, C., Bertrand, C. L., Björnsson, B., de Boer, M. T., de Boer, S. W., Bokkers, R. P. H., Rinkes, I. H. M. Borel, Breitenstein, S., Bruijnen, R. C. G., Bruners, P., Büchler, M. W., Camacho, J. C., Cappelli, A., Carling, U., Chan, B. K. Y., Chang, D. H., choi, J., Font, J. Codina, Crawford, M., Croagh, D., Cugat, E., Davis, R., De Boo, D. W., De Cobelli, F., De Wispelaere, J. F., van Delden, O. M., Delle, M., Detry, O., Díaz-Nieto, R., Dili, A., Erdmann, J. I., Fisher, O., Fondevila, C., Fretland, Å., Borobia, F. Garcia, Gelabert, A., Gérard, L., Giuliante, F., Gobardhan, P. D., Gómez, F., Grünberger, T., Grünhagen, D. J., Guitart, J., Hagendoorn, J., Heil, J., Heise, D., Herrero, E., Hess, G. F., Hoffmann, M. H., Iezzi, R., Imani, F., Nguyen, J., Jovine, E., Kalff, J. C., Kazemier, G., Kingham, T. P., Kleeff, J., Kollmar, O., Leclercq, W. K. G., Ben, S. Lopez, Lucidi, V., MacDonald, A., Madoff, D. C., Manekeller, S., Martel, G., Mehrabi, A., Mehrzad, H., Meijerink, M. R., Menon, K., Metrakos, P., Meyer, C., Moelker, A., Modi, S., Montanari, N., Navines, J., Neumann, U. P., Peddu, P., Primrose, J. N., Qu, X., Raptis, D., Ratti, F., Ridouani, F., Rogan, C., Ronellenfitsch, U., Ryan, S., Sallemi, C., Moragues, J. Sampere, Sandström, P., Sarriá, L., Schnitzbauer, A., Serenari, M., Serrablo, A., Smits, M. L. J., Sparrelid, E., Spüntrup, E., Stavrou, G. A., Sutcliffe, R. P., Tancredi, I., Tasse, J. C., Udupa, V., Valenti, D., Fundora, Y., Vogl, T. J., Wang, X., White, S. A., Wohlgemuth, W. A., Yu, D., Zijlstra, I. A. J., Binkert, C. A., Bemelmans, M. H. A., van der Leij, C., Schadde, E., and van Dam, R. M.

Published
2022
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9. Association of clinical factors and recent anticancer therapy with COVID-19 severity among patients with cancer: a report from the COVID-19 and Cancer Consortium

Author

Grivas, P., Khaki, A.R., Wise-Draper, T.M., French, B., Hennessy, C., Hsu, C.-Y., Shyr, Y., Li, X., Choueiri, T.K., Painter, C.A., Peters, S., Rini, B.I., Thompson, M.A., Mishra, S., Rivera, D.R., Acoba, J.D., Abidi, M.Z., Bakouny, Z., Bashir, B., Bekaii-Saab, T., Berg, S., Bernicker, E.H., Bilen, M.A., Bindal, P., Bishnoi, R., Bouganim, N., Bowles, D.W., Cabal, A., Caimi, P.F., Chism, D.D., Crowell, J., Curran, C., Desai, A., Dixon, B., Doroshow, D.B., Durbin, E.B., Elkrief, A., Farmakiotis, D., Fazio, A., Fecher, L.A., Flora, D.B., Friese, C.R., Fu, J., Gadgeel, S.M., Galsky, M.D., Gill, D.M., Glover, M.J., Goyal, S., Grover, P., Gulati, S., Gupta, S., Halabi, S., Halfdanarson, T.R., Halmos, B., Hausrath, D.J., Hawley, J.E., Hsu, E., Huynh-Le, M., Hwang, C., Jani, C., Jayaraj, A., Johnson, D.B., Kasi, A., Khan, H., Koshkin, V.S., Kuderer, N.M., Kwon, D.H., Lammers, P.E., Li, A., Loaiza-Bonilla, A., Low, C.A., Lustberg, M.B., Lyman, G.H., McKay, R.R., McNair, C., Menon, H., Mesa, R.A., Mico, V., Mundt, D., Nagaraj, G., Nakasone, E.S., Nakayama, J., Nizam, A., Nock, N.L., Park, C., Patel, J.M., Patel, K.G., Peddi, P., Pennell, N.A., Piper-Vallillo, A.J., Puc, M., Ravindranathan, D., Reeves, M.E., Reuben, D.Y., Rosenstein, L., Rosovsky, R.P., Rubinstein, S.M., Salazar, M., Schmidt, A.L., Schwartz, G.K., Shah, M.R., Shah, S.A., Shah, C., Shaya, J.A., Singh, S.R.K., Smits, M., Stockerl-Goldstein, K.E., Stover, D.G., Streckfuss, M., Subbiah, S., Tachiki, L., Tadesse, E., Thakkar, A., Tucker, M.D., Verma, A.K., Vinh, D.C., Weiss, M., Wu, J.T., Wulff-Burchfield, E., Xie, Z., Yu, P.P., Zhang, T., Zhou, A.Y., Zhu, H., Zubiri, L., Shah, D.P., Warner, J.L., and Lopes, GdL.

Published
2021
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10. Dose–effect relationships in neuroendocrine tumour liver metastases treated with [166Ho]-radioembolization.

Author

Ramdhani, K., Beijer-Verduin, J., Ebbers, S. C., van Rooij, R., Smits, M. L. J., Bruijnen, R. C. G., de Jong, H. W. A. M., Lam, M. G. E. H., and Braat, A. J. A. T.

Subjects
DOSE-response relationship (Radiation), NEUROENDOCRINE tumors, PROGRESSION-free survival, MAGNETIC resonance imaging, OVERALL survival, ABSORBED dose, LIVER
Abstract

Purpose: Aim of this study was to investigate a dose-response relationship, dose-toxicity relationship, progression free survival (PFS) and overall survival (OS) in neuroendocrine tumour liver metastases (NELM) treated with holmium-166-microspheres radioembolization ([166Ho]-radioembolization). Materials and methods: Single center, retrospective study included patients with NELM that received [166Ho]-radioembolization with post-treatment SPECT/CT and CECT or MRI imaging for 3 months follow-up. Post-treatment SPECT/CT was used to calculate tumour (Dt) and whole liver healthy tissue (Dh) absorbed dose. Clinical and laboratory toxicity was graded by Common Terminology Criteria for Adverse Events (CTCAE), version 5 at baseline and three-months follow-up. Response was determined according to RECIST 1.1. The tumour and healthy doses was correlated to lesion-based objective response and patient-based toxicity. Kaplan Meier analyses were performed for progression free survival (PFS) and overall survival (OS). Results: Twenty-seven treatments in 25 patients were included, with a total of 114 tumours. Median follow-up was 14 months (3 – 82 months). Mean Dt in non-responders was 68 Gy versus 118 Gy in responders, p = 0.01. ROC analysis determined 86 Gy to have the highest sensitivity and specificity, resp. 83% and 81%. Achieving a Dt of ≥ 120 Gy provided the highest likelihood of response (90%) for obtaining response. Sixteen patients had grade 1–2 clinical toxicity and only one patient grade 3. No clear healthy liver dose-toxicity relationship was found. The median PFS was 15 months (95% CI [10.2;19.8]) and median OS was not reached. Conclusion: This study confirms the safety and efficacy of [166Ho]-radioembolization in NELM in a real-world setting. A clear dose–response relationship was demonstrated and future studies should aim at a Dt of ≥ 120 Gy, being predictive of response. No dose-toxicity relationship could be established. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Accurate Placement and Revisions for Cervical Pedicle Screws Placed With or Without Navigation: A Systematic Review and Meta-Analysis.

Author

Bindels, B. J. J., Dronkers, B. E. G., Smits, M. L. J., and Verlaan, J. J.

Subjects
FLUOROSCOPY, SCREWS, THREE-dimensional imaging, SURGICAL complications, SURGERY, COMPUTER-assisted surgery
Abstract

Study Design: Systematic review and meta-analysis. Objectives: To evaluate the accuracy of placement for cervical pedicle screws with and without the use of spinal navigation. Methods: A structured search was conducted in electronic databases without any language or date restrictions. Eligible studies reported the proportion of accurately placed cervical pedicle screws measured on intraoperative or postoperative 3D imaging, and reported whether intraoperative navigation was used during screw placement. Randomized Studies (MINORS) criteria were used to evaluate the methodological quality of how accuracy was assessed for cervical pedicle screws. Results: After screening and critical appraisal, 4697 cervical pedicle screws from 18 studies were included in the meta-analysis. The pooled proportion for cervical pedicle screws with a breach up to 2 mm was 94% for navigated screws and did not differ from the pooled proportion for non-navigated screws (96%). The pooled proportion for cervical pedicle screws placed completely in the pedicle was 76% for navigated screws and did not differ from the pooled proportion for non-navigated screws (82%). Intraoperative screw reposition rates and screw revision rates as a result of postoperative imaging also did not differ between navigated and non-navigated screw placement. Conclusions: This systematic review and meta-analysis found that the use of spinal navigation systems does not significantly improve the accuracy of placement of cervical pedicle screws compared to screws placed without navigation. Future studies evaluating intraoperative navigation for cervical pedicle screw placement should focus on the learning curve, postoperative complications, and the complexity of surgical cases. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Organic phosphorus in the terrestrial environment: a perspective on the state of the art and future priorities

Author

George, T. S., Giles, C. D., Menezes-Blackburn, D., Condron, L. M., Gama-Rodrigues, A. C., Jaisi, D., Lang, F., Neal, A. L., Stutter, M. I., Almeida, D. S., Bol, R., Cabugao, K. G., Celi, L., Cotner, J. B., Feng, G., Goll, D. S., Hallama, M., Krueger, J., Plassard, C., Rosling, A., Darch, T., Fraser, T., Giesler, R., Richardson, A. E., Tamburini, F., Shand, C. A., Lumsdon, D. G., Zhang, H., Blackwell, M. S. A., Wearing, C., Mezeli, M. M., Almås, Å. R., Audette, Y., Bertrand, I., Beyhaut, E., Boitt, G., Bradshaw, N., Brearley, C. A., Bruulsema, T. W., Ciais, P., Cozzolino, V., Duran, P. C., Mora, M. L., de Menezes, A. B., Dodd, R. J., Dunfield, K., Engl, C., Frazão, J. J., Garland, G., Jiménez, J. L. González, Graca, J., Granger, S. J., Harrison, A. F., Heuck, C., Hou, E. Q., Johnes, P. J., Kaiser, K., Kjær, H. A., Klumpp, E., Lamb, A. L., Macintosh, K. A., Mackay, E. B., McGrath, J., McIntyre, C., McLaren, T., Mészáros, E., Missong, A., Mooshammer, M., Negrón, C. P., Nelson, L. A., Pfahler, V., Poblete-Grant, P., Randall, M., Seguel, A., Seth, K., Smith, A. C., Smits, M. M., Sobarzo, J. A., Spohn, M., Tawaraya, K., Tibbett, M., Voroney, P., Wallander, H., Wang, L., Wasaki, J., and Haygarth, P. M.

Published
2018
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18. Aortic stiffness and brain integrity in elderly patients with cognitive and functional complaints

Author

Tap L, van Opbroek A, Niessen WJ, Smits M, and Mattace-Raso FUS

Subjects
vascular aging, white matter hyperintensities, gray matter, older persons, cognitive complaints, functional decline, Geriatrics, RC952-954.6
Abstract

Lisanne Tap,1 Annegreet van Opbroek,2 Wiro J Niessen,2,3 Marion Smits,4 Francesco US Mattace-Raso1 1Department of Internal Medicine, Section of Geriatric Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands; 2Department of Medical Informatics and Radiology, Biomedical Imaging Group Rotterdam, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands; 3Imaging Physics, Faculty of Applied Sciences, Delft University of Technology, Delft, the Netherlands; 4Department of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands Purpose: Cerebral white matter lesions (WML) and brain atrophy are frequent in older persons and are associated with adverse outcomes. It has been suggested that aortic stiffness plays a role in the pathogenesis of WML and gray matter (GM) loss. There is, however, little evidence on the association between aortic stiffness and brain integrity in older patients. In this study, we investigated whether aortic stiffness is associated with WML and GM volume in older patients with cognitive and functional complaints. Patients and methods: Fazekas score was used to analyze WML on brain imaging data of 84 persons; in a subanalysis on 42 MRI scans, the exact volume of white matter hyperintensities (WMH) and GM was determined using a brain-tissue and WMH tool. Aortic stiffness, measured as aortic pulse wave velocity (aPWV) and central pulse pressure (cPP), and blood pressure levels were non-invasively measured by the Mobil-O-Graph. Results: Mean age was 76.6 (±6.8) years. Age was correlated with cPP (Spearman’s ρ =0.296, P=0.008), aPWV (r²=0.785, P

Published
2018

21. Addressing dissociation symptoms with trauma-focused mentalization-based treatment.

Author

Rüfenacht, E., Shaverin, L., Stubley, J., Smits, M. L., Bateman, A., Fonagy, P., and Luyten, P.

Subjects
TREATMENT of post-traumatic stress disorder, ADVERSE childhood experiences, DISSOCIATIVE disorders, PSYCHOLOGY, ATTACHMENT behavior, PATIENTS' attitudes, THEORY, PSYCHOTHERAPY, MENTAL health services, BULLYING, TRUST
Abstract

A significant number of individuals receiving mental health care exhibit a history of traumatic experiences. Accompanying dissociative symptoms often amplify the complexity of their required treatment. This article introduces a novel understanding and treatment approach for post-traumatic stress symptoms, inclusive of dissociation, derived from attachment and mentalization theories. Initially, we outline the different expressions of dissociation and the prevailing knowledge concerning their associations with diverse clinical manifestations and their role in trauma. We subsequently reinterpret these clinical symptoms through an attachment and mentalization lens, then proceed to elaborate on the new trauma-focused mentalization-based treatment and its therapeutic objectives. The article culminates with a case study that exemplifies the application of this approach in a clinical setting. [ABSTRACT FROM AUTHOR]

Published
2023
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23. The effects of a multispecies probiotic on migraine and markers of intestinal permeability-results of a randomized placebo-controlled study

Author

de Roos, N M, van Hemert, S, Rovers, J M P, Smits, M G, and Witteman, B J M

Subjects
Digestive organs -- Health aspects, Migraine -- Development and progression -- Diet therapy, Probiotics -- Usage -- Health aspects -- Physiological aspects, Food/cooking/nutrition, Health
Abstract

Background/Objectives: Migraine, associated with several gastrointestinal disorders, may result from increased intestinal permeability, allowing endotoxins to enter the bloodstream. We tested whether probiotics could reduce migraine through an effect on intestinal permeability and inflammation. Subjects/Methods: In total, 63 patients were randomly allocated to the probiotic (n=31) or the placebo group (n=32). Participants ingested a multispecies probiotic (5x10.sup.9 colony-forming units) or placebo daily for 12 weeks. Migraine was assessed with the Migraine Disability Assessment Scale (MIDAS), the Headache Disability Inventory (HDI) and headache diaries. At baseline and 12 weeks, intestinal permeability was measured with the urinary lactulose/mannitol test and fecal and serum zonulin; inflammation was measured from interleukin (IL) -6, IL-10, tumor necrosis factor-[alpha] and C-reactive protein in serum. Results: The MIDAS migraine intensity score significantly decreased in both groups (P Conclusions: In this study, we could not confirm significant benefit from a multispecies probiotic compared to a placebo on the outcome parameters of migraine and intestinal integrity., Author(s): N M de Roos [sup.1] , S van Hemert [sup.2] , J M P Rovers [sup.3] , M G Smits [sup.3] , B J M Witteman [sup.1] [sup.4] Author [...]

Published
2017
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27. Mutations in the heparan sulfate backbone elongating enzymes EXT1 and EXT2 have no major effect on endothelial glycocalyx and the glomerular filtration barrier

Author

Khalil, Ramzi, Boels, Margien G. S., Bezuijen, A., Boers, J. E., de Bruin, P. C., van Dijk, M. A. A. M., Drillenburg, P., Hamel, A. F., Hazelbag, H. M., Jonges, G. N., Kibbelaar, R. E., Lam, K. H., van der Linden, H., van Marsdijk, J., Meijer, C., Nagtegaal, I. D., Oudejans, J. J., Roelofs, J. J. T. H., Rozendaal, L., Sastrowijoto, S. H., Smits, M. M., Stavast, J., van den Berg, Bernard M., Bruijn, Jan A., Rabelink, Ton J., Hogendoorn, Pancras C. W., Baelde, Hans J., Neurology, Pathology, Internal medicine, ACS - Diabetes & metabolism, and ACS - Pulmonary hypertension & thrombosis

Subjects
Hereditary multiple exostosis, General Medicine, Multiple osteochondromas, N-Acetylglucosaminyltransferases, Glycocalyx, Bone neoplasm, urologic and male genital diseases, Glomerular filtration barrier, Proteinuria, Mutation, Genetics, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14], Humans, Albuminuria, Heparitin Sulfate, Endothelium, Molecular Biology
Abstract

In this study, the effect of heterozygous germline mutations in the heparan sulfate (HS) glycosaminoglycan chain co-polymerases EXT1 and EXT2 on glomerular barrier function and the endothelial glycocalyx in humans is investigated. Heparan sulfate (HS) glycosaminoglycans are deemed essential to the glomerular filtration barrier, including the glomerular endothelial glycocalyx. Animal studies have shown that loss of HS results in a thinner glycocalyx. Also, decreased glomerular HS expression is observed in various proteinuric renal diseases in humans. A case report of a patient with an EXT1 mutation indicated that this could result in a specific renal phenotype. This patient suffered from multiple osteochondromas, an autosomal dominant disease caused by mono-allelic germline mutations in the EXT1 or EXT2 gene. These studies imply that HS is indeed essential to the glomerular filtration barrier. However, loss of HS did not lead to proteinuria in various animal models. We demonstrate that multiple osteochondroma patients do not have more microalbuminuria or altered glycocalyx properties compared to age-matched controls (n = 19). A search for all Dutch patients registered with both osteochondroma and kidney biopsy (n = 39) showed that an EXT1 or EXT2 mutation does not necessarily lead to specific glomerular morphological phenotypic changes. In conclusion, this study shows that a heterozygous mutation in the HS backbone elongating enzymes EXT1 and EXT2 in humans does not result in (micro)albuminuria, a specific renal phenotype or changes to the endothelial glycocalyx, adding to the growing knowledge on the role of EXT1 and EXT2 genes in pathophysiology.

Published
2022

28. Advanced MR Techniques for Preoperative Glioma Characterization: Part 2

Author

Hangel, Gilbert, Schmitz-Abecassis, Bárbara, Pinto, Joana, Sollmann, Nico, Tseng, C., Vos, F.M., Warnert, E.A.H., Smits, M., and Petr, Jan

Subjects
brain, glioma, GliMR 2.0, contrasts, level of clinical validation, preoperative
Abstract

Preoperative clinical MRI protocols for gliomas, brain tumors with dismal outcomes due to their infiltrative properties, still rely on conventional structural MRI, which does not deliver information on tumor genotype and is limited in the delineation of diffuse gliomas. The GliMR COST action wants to raise awareness about the state of the art of advanced MRI techniques in gliomas and their possible clinical translation. This review describes current methods, limits, and applications of advanced MRI for the preoperative assessment of glioma, summarizing the level of clinical validation of different techniques. In this second part, we review magnetic resonance spectroscopy (MRS), chemical exchange saturation transfer (CEST), susceptibility-weighted imaging (SWI), MRI-PET, MR elastography (MRE), and MR-based radiomics applications. The first part of this review addresses dynamic susceptibility contrast (DSC) and dynamic contrast-enhanced (DCE) MRI, arterial spin labeling (ASL), diffusion-weighted MRI, vessel imaging, and magnetic resonance fingerprinting (MRF). Evidence Level: 3. Technical Efficacy: Stage 2.

Published
2023

29. Advanced MR Techniques for Preoperative Glioma Characterization: Part 1

Author

Hirschler, Lydiane, Sollmann, Nico, Schmitz-Abecassis, Bárbara, Pinto, Joana, Arzanforoosh, Fatemehsadat, Tseng, C., Vos, F.M., Warnert, E.A.H., and Smits, M.

Subjects
brain, glioma, GliMR 2.0, contrasts, level of clinical validation, preoperative
Abstract

Preoperative clinical magnetic resonance imaging (MRI) protocols for gliomas, brain tumors with dismal outcomes due to their infiltrative properties, still rely on conventional structural MRI, which does not deliver information on tumor genotype and is limited in the delineation of diffuse gliomas. The GliMR COST action wants to raise awareness about the state of the art of advanced MRI techniques in gliomas and their possible clinical translation or lack thereof. This review describes current methods, limits, and applications of advanced MRI for the preoperative assessment of glioma, summarizing the level of clinical validation of different techniques. In this first part, we discuss dynamic susceptibility contrast and dynamic contrast-enhanced MRI, arterial spin labeling, diffusion-weighted MRI, vessel imaging, and magnetic resonance fingerprinting. The second part of this review addresses magnetic resonance spectroscopy, chemical exchange saturation transfer, susceptibility-weighted imaging, MRI-PET, MR elastography, and MR-based radiomics applications. Evidence Level: 3. Technical Efficacy: Stage 2.

Published
2023

30. Correction to: Organic phosphorus in the terrestrial environment: a perspective on the state of the art and future priorities

Author

George, T. S., Giles, C. D., Menezes-Blackburn, D., Condron, L. M., Gama-Rodrigues, A. C., Jaisi, D., Lang, F., Neal, A. L., Stutter, M. I., Almeida, D. S., Bol, R., Cabugao, K. G., Celi, L., Cotner, J. B., Feng, G., Goll, D. S., Hallama, M., Krueger, J., Plassard, C., Rosling, A., Darch, T., Fraser, T., Giesler, R., Richardson, A. E., Tamburini, F., Shand, C. A., Lumsdon, D. G., Zhang, H., Blackwell, M. S. A., Wearing, C., Mezeli, M. M., Almås, Å. R., Audette, Y., Bertrand, I., Beyhaut, E., Boitt, G., Bradshaw, N., Brearley, C. A., Bruulsema, T. W., Ciais, P., Cozzolino, V., Duran, P. C., Mora, M. L., de Menezes, A. B., Dodd, R. J., Dunfield, K., Engl, C., Frazão, J. J., Garland, G., González Jiménez, J. L., Graca, J., Granger, S. J., Harrison, A. F., Heuck, C., Hou, E. Q., Johnes, P. J., Kaiser, K., Kjær, H. A., Klumpp, E., Lamb, A. L., Macintosh, K. A., Mackay, E. B., McGrath, J., McIntyre, C., McLaren, T., Mészáros, E., Missong, A., Mooshammer, M., Negrón, C. P., Nelson, L. A., Pfahler, V., Poblete-Grant, P., Randall, M., Seguel, A., Seth, K., Smith, A. C., Smits, M. M., Sobarzo, J. A., Spohn, M., Tawaraya, K., Tibbett, M., Voroney, P., Wallander, H., Wang, L., Wasaki, J., and Haygarth, P. M.

Published
2018
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32. Standardised lesion segmentation for imaging biomarker quantitation:a consensus recommendation from ESR and EORTC

Author

DeSouza, N.M., Lugt, A. van der, Deroose, C.M., Alberich-Bayarri, A., Bidaut, L., Fournier, L., Costaridou, L., Oprea-Lager, D.E., Kotter, E., Smits, M., Mayerhoefer, M.E., Boellaard, R., Caroli, A., Geus-Oei, L.F. de, Kunz, W.G., Oei, E.H., Lecouvet, F., Franca, M., Loewe, C., Lopci, E., Caramella, C., Persson, A., Golay, X., Dewey, M., O'Connor, J.P.B., DeGraaf, P., Gatidis, S., Zahlmann, G., European Soc Radiology, European Org Res Treatment Canc, Radiology and nuclear medicine, AII - Cancer immunology, AII - Inflammatory diseases, CCA - Cancer biology and immunology, CCA - Imaging and biomarkers, Amsterdam Neuroscience - Brain Imaging, and Radiology & Nuclear Medicine

Subjects
Science & Technology, PET/CT, Segmentation and standardisation, Organ-specific, Radiology, Nuclear Medicine & Medical Imaging, mDelphi, Region of interest, Modality-specific, CANCER, CLASSIFICATION, VALIDATION, SDG 3 - Good Health and Well-being, Radiology, Nuclear Medicine and imaging, Radiologi och bildbehandling, Life Sciences & Biomedicine, MRI, Radiology, Nuclear Medicine and Medical Imaging
Abstract

Background Lesion/tissue segmentation on digital medical images enables biomarker extraction, image-guided therapy delivery, treatment response measurement, and training/validation for developing artificial intelligence algorithms and workflows. To ensure data reproducibility, criteria for standardised segmentation are critical but currently unavailable. Methods A modified Delphi process initiated by the European Imaging Biomarker Alliance (EIBALL) of the European Society of Radiology (ESR) and the European Organisation for Research and Treatment of Cancer (EORTC) Imaging Group was undertaken. Three multidisciplinary task forces addressed modality and image acquisition, segmentation methodology itself, and standards and logistics. Devised survey questions were fed via a facilitator to expert participants. The 58 respondents to Round 1 were invited to participate in Rounds 2-4. Subsequent rounds were informed by responses of previous rounds. Results/conclusions Items with >= 75% consensus are considered a recommendation. These include system performance certification, thresholds for image signal-to-noise, contrast-to-noise and tumour-to-background ratios, spatial resolution, and artefact levels. Direct, iterative, and machine or deep learning reconstruction methods, use of a mixture of CE marked and verified research tools were agreed and use of specified reference standards and validation processes considered essential. Operator training and refreshment were considered mandatory for clinical trials and clinical research. Items with a 60-74% agreement require reporting (site-specific accreditation for clinical research, minimal pixel number within lesion segmented, use of post-reconstruction algorithms, operator training refreshment for clinical practice). Items with Funding Agencies|European Union [826494, 952159, 952172, 101057699]; NIH/NCI Cancer Center Support Grant [P30 CA008748]; National Institute for Health Research University College London Hospitals Biomedical Research Centre; French government under management of the Agence Nationale de la Recherche as part of the "Investissements davenir" program [ANR19-P3IA-0001]

Published
2022

33. Disconcordance between different molecular methods to assess homozygous deletion of the CDKN2A/B locus in IDH-mutant astrocytomas

Author

Vallentgoed, W., van Dijk, E., van den Bent, M. J., Draaisma, K., van Eijk, P., van Garderen, K., de Heer, I, Hoogstrate, Y., Kouwenhoven, M., Kros, J. M., de Leng, W., van Nee, M., Niers, A., Robe, P., Smits, M., Westerman, B., van de Wiel, M., Ylstra, B., Wesseling, P., French, P. J., Public and occupational health, Neurology, Epidemiology and Data Science, APH - Methodology, Pathology, and CCA - Cancer biology and immunology

Published
2022

34. INTEGRATIVE MOLECULAR ANALYSIS OF MATCHED PRIMARY AND RECURRENT IDH-MUTANT ASTROCYTOMA; AN UPDATE FROM THE GLASS-NL CONSORTIUM

Author

Vallentgoed, W. R., Hoogstrate, Y., van Dijk, E., van Garderen, K., Niers, A., van den Bent, M. J., Draaisma, K., van Eijk, P., de Heer, I, Kouwenhoven, M., Kros, J. M., de Leng, W., van Nee, M., Robe, P., Smits, M., Tesileanu, M., Westerman, B., van de Wiel, M., Ylstra, B., Wesseling, P., French, P. J., Public and occupational health, Neurology, Epidemiology and Data Science, APH - Methodology, Pathology, and CCA - Cancer biology and immunology

Published
2022

38. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

Author

Braam, W., Didden, R., and Smits, M.

Abstract

Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep disturbance was assessed in a randomized double-blind placebo-controlled trial with 51 individuals with ID. All of these individuals presented with chronic ideopathic sleep disturbance for more than 1 year. The study consisted of a 1-week baseline, followed by 4 weeks of treatment. Parents or other caregivers recorded lights off time, sleep onset time, night waking, wake up time and epileptic seizures. Endogenous melatonin cycle was measured in saliva before and after treatment. Results: Compared with placebo, melatonin significantly advanced mean sleep onset time by 34 min, decreased mean sleep latency by 29 min, increased mean total sleep time by 48 min, reduced the mean number of times the person awoke during the night by 0.4, decreased the mean duration of these night waking periods by 17 min and advanced endogenous melatonin onset at night by an average of 2.01 h. Lights off time, sleep offset time and the number of nights per week with night waking did not change. Only few minor or temporary adverse reactions and no changes in seizure frequency were reported. Conclusions: Melatonin treatment improves some aspects of chronic sleep disturbance in individuals with ID. (Contains 1 figure and 3 tables.)

Published
2008
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47. Incorporating radiomics into clinical trials: expert consensus endorsed by the European Society of Radiology on considerations for data-driven compared to biologically driven quantitative biomarkers (Jan , 10.1007/s00330-020-07598-8, 2021)

Author

Fournier, L., Costaridou, L., Bidaut, L., Michoux, N., Lecouvet, F.E., Geus-Oei, L.F. de, Boellaard, R., Oprea-Lager, D.E., Obuchowski, N.A., Caroli, A., Kunz, W.G., Oei, E.H., O'Connor, J.P.B., Mayerhoefer, M.E., Franca, M., Alberich-Bayarri, A., Deroose, C.M., Loewe, C., Manniesing, R., Caramella, C., Lopci, E., Lassau, N., Persson, A., Achten, R., Rosendahl, K., Clement, O., Kotter, E., Golay, X., Smits, M., Dewey, M., Sullivan, D.C., Lugt, A. van der, deSouza, N.M., and European Soc Radiology

Subjects
GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries)
Abstract

A Correction to this paper has been published

Published
2021

50. Incorporating radiomics into clinical trials: expert consensus on considerations for data-driven compared to biologically driven quantitative biomarkers

Author

Fournier, L., Costaridou, L., Bidaut, L., Michoux, N., Lecouvet, F.E., Geus-Oei, L.F. de, Boellaard, R., Oprea-Lager, D.E., Obuchowski, N.A., Caroli, A., Kunz, W.G., Oei, E.H., O'Connor, J.P.B., Mayerhoefer, M.E., Franca, M., Alberich-Bayarri, A., Deroose, C.M., Loewe, C., Manniesing, R., Caramella, C., Lopci, E., Lassau, N., Persson, A., Achten, R., Rosendahl, K., Clement, O., Kotter, E., Golay, X., Smits, M., Dewey, M., Sullivan, D.C., Lugt, A. van der, and deSouza, N.M.

Subjects
Clinical trial, Statistics and numerical data, Validation studies, Radiology, Standardization
Abstract

Existing quantitative imaging biomarkers (QIBs) are associated with known biological tissue characteristics and follow a well-understood path of technical, biological and clinical validation before incorporation into clinical trials. In radiomics, novel data-driven processes extract numerous visually imperceptible statistical features from the imaging data with no a priori assumptions on their correlation with biological processes. The selection of relevant features (radiomic signature) and incorporation into clinical trials therefore requires additional considerations to ensure meaningful imaging endpoints. Also, the number of radiomic features tested means that power calculations would result in sample sizes impossible to achieve within clinical trials. This article examines how the process of standardising and validating data-driven imaging biomarkers differs from those based on biological associations. Radiomic signatures are best developed initially on datasets that represent diversity of acquisition protocols as well as diversity of disease and of normal findings, rather than within clinical trials with standardised and optimised protocols as this would risk the selection of radiomic features being linked to the imaging process rather than the pathology. Normalisation through discretisation and feature harmonisation are essential pre-processing steps. Biological correlation may be performed after the technical and clinical validity of a radiomic signature is established, but is not mandatory. Feature selection may be part of discovery within a radiomics-specific trial or represent exploratory endpoints within an established trial; a previously validated radiomic signature may even be used as a primary/secondary endpoint, particularly if associations are demonstrated with specific biological processes and pathways being targeted within clinical trials. KEY POINTS: • Data-driven processes like radiomics risk false discoveries due to high-dimensionality of the dataset compared to sample size, making adequate diversity of the data, cross-validation and external validation essential to mitigate the risks of spurious associations and overfitting. • Use of radiomic signatures within clinical trials requires multistep standardisation of image acquisition, image analysis and data mining processes. • Biological correlation may be established after clinical validation but is not mandatory. ispartof: EUROPEAN RADIOLOGY vol:31 issue:8 pages:6001-6012 ispartof: location:Germany status: published

Published
2021

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