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001-es BibID:	BIBFORM113554
035-os BibID:	(scopus)85152618871 (wos)000972163300001
Első szerző:	Loevner, Laurie A.
Cím:	Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System / Loevner Laurie A., Kolumban Balint, Hutóczki Gábor, Dziadziuszko Katarzyna, Bereczki Daniel, Bago Attila, Pichiecchio Anna
Dátum:	2023
ISSN:	0020-9996
Megjegyzések:	Objectives: Developing new high relaxivity gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) allowing dose reduction while maintaining similar diagnostic efficacy is needed, especially in the con- text of gadolinium retention in tissues. This study aimed to demonstrate that contrast-enhanced MRI of the central nervous system (CNS) with gadopiclenol at 0.05 mmol/kg is not inferior to gadobutrol at 0.1 mmol/kg, and superior to unenhanced MRI. Materials and Methods: PICTURE is an international, randomized, double- blinded, controlled, cross-over, phase III study, conducted between June 2019 and September 2020. Adult patients with CNS lesions were randomized to undergo 2 MRIs (interval, 2?14 days) with gadopiclenol (0.05 mmol/kg) then gadobutrol (0.1 mmol/kg) or vice versa. The primary criterion was lesion visualization based on 3 parameters (border delineation, internal morphology, and contrast enhancement), assessed by 3 off-site blinded readers. Key secondary outcomes included lesion-to-background ratio, enhancement percentage, contrast-to-noise ratio, overall diagnostic preference, and adverse events. Results: Of the 256 randomized patients, 250 received at least 1 GBCA adminis- tration (mean [SD] age, 57.2 [13.8] years; 53.6% women). The statistical noninferiority of gadopiclenol (0.05 mmol/kg) to gadobutrol (0.1 mmol/kg) was achieved for all parameters and all readers (n = 236, lower limit 95% confidence interval of the difference ??0.06, above the noninferiority margin [?0.35], P < 0.0001), as well as its statistical superiority over unenhanced images (n = 239, lower limit 95% confidence interval of the difference ?1.29, P < 0.0001). Enhancement percentage and lesion-to-background ratio were higher with gadopiclenol for all readers (P < 0.0001), and contrast-to-noise ratio was higher for 2 readers (P = 0.02 and P < 0.0001). Three blinded readers preferred images with gadopiclenol for 44.8%, 54.4%, and 57.3% of evaluations, reported no preference for 40.7%, 21.6%, and 23.2%, and preferred images with gadobutrol for 14.5%, 24.1%, and 19.5% (P < 0.001). Adverse events reported after MRI were similar for gadopiclenol (14.6% of patients) and gadobutrol (17.6%). Adverse events considered related to gadopiclenol (4.9%) and gadobutrol (6.9%) were mainly injection site reactions, and none was serious. Conclusions: Gadopiclenol at 0.05 mmol/kg is not inferior to gadobutrol at 0.1 mmol/kg for MRI of the CNS, confirming that gadopiclenol can be used at half the gadolinium dose used for other GBCAs to achieve similar clinical efficacy.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Investigative Radiology. - 58 : 5 (2023), p. 307-313. -
További szerzők:	Kolumban Bálint Hutóczki Gábor (1983-) (Ph.D. hallgató) Dziadziuszko, Katarzyna Bereczki Dániel (1960-) (neurológus) Bagó Attila Pichiecchio, Anna
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001-es BibID:	BIBFORM057206
Első szerző:	Szűcs-Farkas Zsolt
Cím:	Diagnostic accuracy of computed tomography pulmonary angiography with reduced radiation and contrast material dose : a prospective randomized clinical trial / Zsolt Szucs-Farkas, Andreas Christe, Boglarka Megyeri, Martin Rohacek, Peter Vock, Endre V. Nagy, Johannes T. Heverhagen, Sebastian T. Schindera
Dátum:	2014
ISSN:	0020-9996
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Investigative Radiology. - 49 : 4 (2014), p. 201-208. -
További szerzők:	Christe, Andreas Megyeri Boglárka (1972-) (orvos) Rohacek, Martin Vock, Peter (radiológus) Nagy Endre V. (1957-) (belgyógyász, endokrinológus) Heverhagen, Johannes T. Schindera, Sebastian T.
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