Multihance Versus Magnevist in Breast MRI

Breast Cancer Clinical Trial

— DETECT  

Official title:

Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486473
• Other study ID #: MH 131
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2007
• Last updated: July 14, 2010
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2010
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provides written informed consent

• Female

• Age 18 years or older

• Suspicious or known breast lesion based on results from mammography or ultrasound

• Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam

Exclusion Criteria:

• Body weight > 100 kg

• Pregnant or lactating

• Server or end-stage organ failure

• Moderate to severe renal impairment

• Undergoing radiotherapy or completed radiotherapy in the last 18 months

• Chemotherapy within 6 months of the 1st MRI exam

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Multihance
0.5 Molar at a single dose injection
• Magnevist
0.5M at a single dose injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity in diagnosing breast lesions compared to histopathology results		up to 6 months	No
Secondary	Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels		up to 6 months	No