Multihance at 3 Tesla (3T) in Brain Tumors

Brain Tumor Clinical Trial

Official title:

A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395863
• Other study ID #: MH 126
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2015
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the efficacy of MultiHance and Magnevist

Description:

The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Drug:
• Multihance
0.5 M at a single injection
• Arm 2 - Magnevist
0.5 M Magnevist at a single dose injection

Locations

Country	Name	City	State
United States	Bracco Diagnostics, Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

References & 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 te — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lesion Border Delineation	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.	Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Secondary	Lesion Contrast Enhancement 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.	Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Secondary	Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Secondary	Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Secondary	Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Secondary	Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Secondary	Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Secondary	Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Secondary	Percentage of Lesion Contrast Enhancement (LCE) - Reader 1	Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]	Postdose
Secondary	Percentage of Contrast Enhancement of the Lesion - Reader 2	Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]	Postdose
Secondary	Percentage of Contrast Enhancement of the Lesion - Reader 3	Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]	Postdose