A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain

Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00323102

Acronym

ENHANCE

Enrollment

114

Registered

2006-05-09

Start date

2006-05-31

Completion date

2007-03-31

Last updated

2008-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Pathology

Brief summary

This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication

Interventions

DRUGMultihance

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days

Exclusion criteria

* Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams

Design outcomes

Primary

Measure	Time frame
Superiority of Multihance in terms of by-patient global diagnostic performance	immediately post dose

Secondary

Measure	Time frame
To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity	immediately post dose
To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions	immediately post dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026