Evidence map›Paper›PMID 25300984›Full record

Trial reportAJNR. American journal of neuroradiology2015

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).

K R Maravilla, M P Smith, J Vymazal, M Goyal, M Herman, J J Baima, R Babbel, M Vaneckova, J Žižka, C Colosimo and 9 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in AJNR. American journal of neuroradiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01613417 (Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01613417 phase4completednot on this map

Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)

TypeinterventionalSponsorBracco Diagnostics, IncRan2012 to 2014Enrolled229ConditionsBrain DiseaseArmsgadoteridol, gadobutrol
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
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  8. Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients.Journal of magnetic resonance imaging : JMRI · 2020
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  10. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 19 institutions in 7 countries.

K R MaravillaFrom the MR Research Laboratory (K.R.M.), University of Washington, Seattle, Washington kmarav@uw.edu.
M P SmithDepartment of Radiology (M.P.S.), Beth Israel Deaconess Medical Center, Boston, Massachusetts.
J VymazalDepartment of Radiology (J.V.), Na Homolce Hospital, Prague, Czech Republic.
M GoyalSeaman Family MR Research Centre (M.G.), University of Calgary, Calgary, Alberta, Canada.
M HermanDepartment of Radiology (M.H.), University Hospital Olomouc, Olomouc, Czech Republic.
J J BaimaClinical Radiologists Service Corporation (J.J.B.), Memorial Medical Center, Springfield, Illinois.
R BabbelGood Samaritan Regional Medical Center (R.B.), Corvallis, Oregon.
M VaneckovaDepartment of Magnetic Resonance (M.V.), General University Hospital, Prague, Czech Republic.
J ŽižkaDepartment of Diagnostic Radiology (J.Ž.), University Hospital Hradec Králové and Faculty of Medicine in Hradec Králové, Charles University, Prague, Czech Republic.
C ColosimoIstituto di Radiologia (C.C.), Policlinico "Agostino Gemelli," Rome, Italy.
M Urbańczyk-ZawadzkaDepartment of Radiology (M.U.-Z.), John Paul II Hospital, Krakow, Poland.
M MechlDepartment of Radiology (M.M.), University Hospital Brno-Bohunice, Brno, Czech Republic.
A K BagDepartment of Radiology (A.K.B.), University of Alabama at Birmingham Medical Center, Birmingham, Alabama.
S BastianelloDepartment of Neuroradiology (S.B), University of Pavia, Pavia, Italy.
E BueltmannInstitute for Diagnostic and Interventional Neuroradiology (E.B.), Hannover, Germany.
T HiraiDepartment of Diagnostic Radiology (T.H.), Kumamoto University, Honjo, Kumamoto, Japan.
T FrattiniOspedale Valduce (T.F.), Como, Italy.
M A KirchinGlobal Medical and Regulatory Affairs (M.A.K.), Bracco Imaging SpA, Milan, Italy.
G PirovanoGlobal Medical and Regulatory Affairs (G.P.), Bracco Diagnostics, Monroe, New Jersey.
Agostino Gemelli University Polyclinic · ITBeth Israel Deaconess Medical Center · USBracco (Italy) · ITCharles University · CZCS Diagnostics · DEGeneral University Hospital in Prague · CZGood Samaritan Regional Medical Center · USJohn Paul II Hospital · PLKumamoto University Hospital · JPMedizinische Hochschule Hannover · DEMemorial Medical Center · USNa Homolce Hospital · CZOspedale Valduce · ITUniversity Hospital Brno · CZUniversity Hospital Olomouc · CZUniversity of Alabama at Birmingham · USUniversity of Calgary · CAUniversity of Pavia · ITUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeGadobutrol (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

methodsTwo 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.

resultsTwo 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).

conclusionsGadoteridol 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.

Indexed as

AdultAgedBrain NeoplasmsContrast MediaCross-Over StudiesFemaleGadoliniumHeterocyclic CompoundsHumansMagnetic Resonance ImagingMaleMiddle AgedNeuroimagingOrganometallic CompoundsContrast MediagadobutrolGadoliniumgadoteridolHeterocyclic CompoundsOrganometallic Compounds

Identifiers

PMID25300984
PMCPMC7965926
OpenAlexW2157253000

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.