Multihance Versus Magnevist in Breast MRI

NCT ID: NCT00486473

Last Updated: 2010-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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Multihance

0.5 Molar at a single dose injection

Intervention Type DRUG

Magnevist

0.5M at a single dose injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Bracco Diagnostics, Inc.

Principal Investigators

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Gianpaolo Pirovano, MD

Role: STUDY_DIRECTOR

Bracco Dianostics, Inc.

Locations

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Rome, , Italy

Site Status

Countries

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Italy

References

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Martincich L, Faivre-Pierret M, Zechmann CM, Corcione S, van den Bosch HC, Peng WJ, Petrillo A, Siegmann KC, Heverhagen JT, Panizza P, Gehl HB, Diekmann F, Pediconi F, Ma L, Gilbert FJ, Sardanelli F, Belli P, Salvatore M, Kreitner KF, Weiss CM, Zuiani C. Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial). Radiology. 2011 Feb;258(2):396-408. doi: 10.1148/radiol.10100968. Epub 2010 Dec 16.

Reference Type DERIVED
PMID: 21163915 (View on PubMed)

Other Identifiers

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MH 131

Identifier Type: -

Identifier Source: org_study_id

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