NCT00395863

Brief Summary

Compare the efficacy of MultiHance and Magnevist

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 31, 2009

Completed
Last Updated

November 5, 2020

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

September 12, 2006

Results QC Date

March 30, 2009

Last Update Submit

October 14, 2020

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • Global Diagnostic Preference Between the Two Exams

    Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.

    Postdose Images for MultiHance Exam and for Magnevist Exam Compared

Secondary Outcomes (11)

  • Lesion Border Delineation

    Postdose Images for MultiHance Exam and for Magnevist Exam Compared

  • Lesion Contrast Enhancement Between the Two Exams

    Postdose Images for MultiHance Exam and for Magnevist Exam Compared

  • Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1

    Predose and immediately postdose

  • Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2

    Predose and immediately postdose

  • Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3

    Predose and immediately postdose

  • +6 more secondary outcomes

Study Arms (2)

MultiHance

ACTIVE COMPARATOR

0.5 M MultiHance at a single injection

Drug: Multihance

Magnevist

ACTIVE COMPARATOR

0.5 M Magnevist at a single injection

Drug: Arm 2 - Magnevist

Interventions

MultihanceDRUG

0.5 M at a single injection

Also known as: gadobenate dimeglumine
MultiHance
Arm 2 - MagnevistDRUG

0.5 M Magnevist at a single dose injection

Also known as: gadopentetate dimeglumine
Magnevist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Was 18 years or older
  • Provided written informed consent
  • Scheduled for MRI
  • Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days

You may not qualify if:

  • Pregnant or lactating females
  • Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
  • Congestive heart failure, class IV
  • Previous stroke in the past year
  • Received another contrast agent within 24 hours pre and post each exam
  • Investigational product
  • Contraindications to MRI
  • Severe claustrophobia
  • Surgery with 3 weeks prior
  • Steroid therapy or radiosurgery between two exams

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bracco Diagnostics, Inc.

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

  • Rumboldt Z, Rowley HA, Steinberg F, Maldjian JA, Ruscalleda J, Gustafsson L, Bastianello S. Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. J Magn Reson Imaging. 2009 Apr;29(4):760-7. doi: 10.1002/jmri.21695.

    PMID: 19306364RESULT

MeSH Terms

Conditions

Brain Neoplasms

Interventions

gadobenic acidGadolinium DTPA

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Results Point of Contact

Title
Gianpaolo Pirovano, MD, Executive Director, Head Corporate Medical Development
Organization
Bracco Diagnostics Inc.
gianpaolo.pirovano@diag.bracco.com
609-514-2226

Study Officials

  • Gianpaolo Priovano, M.D.

    Bracco Diagnostics, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2006

First Posted

November 6, 2006

Study Start

November 1, 2006

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

November 5, 2020

Results First Posted

July 31, 2009

Record last verified: 2015-03

Locations

US(1)