CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 229 enrolled
Drug / intervention
gadoteridol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01613417
NCT01613417Phase 4Completed
CompareCT.gov

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)

Bracco Diagnostics, Inc·interventional·Posted Jun 7, 2012·Updated Jul 1, 2015

In Brief

A Phase 4 clinical trial evaluating gadoteridol and gadobutrol for Brain Disease. Completed, enrolled 229 participants across 1 site.

Detailed Summary

This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2012
Enrollment StartAug 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.1 years ago

Interventions

gadoteridoldrug

ProHance 0.1 mmol/kg

gadobutroldrug

Gadovist/Gadavist 0.1 mmol/kg