Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study)
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
25300984
PubMed Central
PMC7965926
DOI
10.3174/ajnr.a4154
PII: ajnr.A4154
Knihovny.cz E-zdroje
- MeSH
- dospělí MeSH
- gadolinium aplikace a dávkování MeSH
- heterocyklické sloučeniny aplikace a dávkování MeSH
- klinické křížové studie MeSH
- kontrastní látky aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonanční tomografie metody MeSH
- nádory mozku diagnóza MeSH
- neurozobrazování metody MeSH
- organokovové sloučeniny aplikace a dávkování MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- gadobutrol MeSH Prohlížeč
- gadolinium MeSH
- gadoteridol MeSH Prohlížeč
- heterocyklické sloučeniny MeSH
- kontrastní látky MeSH
- organokovové sloučeniny MeSH
BACKGROUND AND PURPOSE: Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures, but gadobutrol is formulated at a 2-fold higher (1 mol/L versus 0.5 mol/L) concentration. We sought to determine whether this difference impacts morphologic contrast-enhanced MR imaging. MATERIALS AND METHODS: Two hundred twenty-nine adult patients with suspected or known brain tumors underwent two 1.5T MR imaging examinations with gadoteridol or gadobutrol administered in randomized order at a dose of 0.1 mmol/kg of body weight. Imaging sequences and T1 postinjection timing were identical for both examinations. Three blinded readers evaluated images qualitatively and quantitatively for lesion detection and for accuracy in characterization of histologically confirmed brain tumors. Data were analyzed by using the Wilcoxon signed rank test, the McNemar test, and a mixed model. RESULTS: Two hundred nine patients successfully completed both examinations. No reader noted a significant qualitative or quantitative difference in lesion enhancement, extent, delineation, or internal morphology (P values = .69-1.00). One hundred thirty-nine patients had at least 1 histologically confirmed brain lesion. Two readers found no difference in the detection of patients with lesions (133/139 versus 135/139, P = .317; 137/139 versus 136/139, P = .564), while 1 reader found minimal differences in favor of gadoteridol (136/139 versus 132/139, P = .046). Similar findings were noted for the number of lesions detected and characterization of tumors (malignant/benign). Three-reader agreement for characterization was similar for gadobutrol (66.4% [κ = 0.43]) versus gadoteridol (70.3% [κ = 0.45]). There were no significant differences in the incidence of adverse events (P = .199). CONCLUSIONS: Gadoteridol and gadobutrol at 0.1 mmol/kg of body weight provide similar information for visualization and diagnosis of brain lesions. The 2-fold higher gadolinium concentration of gadobutrol provides no benefit for routine morphologic imaging.
Clinical Radiologists Service Corporation Memorial Medical Center Springfield Illinois
Department of Diagnostic Radiology Kumamoto University Honjo Kumamoto Japan
Department of Magnetic Resonance General University Hospital Prague Czech Republic
Department of Neuroradiology University of Pavia Pavia Italy
Department of Radiology Beth Israel Deaconess Medical Center Boston Massachusetts
Department of Radiology John Paul 2 Hospital Krakow Poland
Department of Radiology Na Homolce Hospital Prague Czech Republic
Department of Radiology University Hospital Brno Bohunice Brno Czech Republic
Department of Radiology University Hospital Olomouc Olomouc Czech Republic
Department of Radiology University of Alabama at Birmingham Medical Center Birmingham Alabama
From the MR Research Laboratory University of Washington Seattle Washington
Global Medical and Regulatory Affairs Bracco Diagnostics Monroe New Jersey
Global Medical and Regulatory Affairs Bracco Imaging SpA Milan Italy
Good Samaritan Regional Medical Center Corvallis Oregon
Institute for Diagnostic and Interventional Neuroradiology Hannover Germany
Istituto di Radiologia Policlinico Agostino Gemelli Rome Italy
Seaman Family MR Research Centre University of Calgary Calgary Alberta Canada
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