Multihance Versus Magnevist in Breast MRI (DETECT)

July 14, 2010 updated by: Bracco Diagnostics, Inc

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

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

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Rome, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity in diagnosing breast lesions compared to histopathology results Time Frame: up to 6 months	up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels Time Frame: up to 6 months	up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bracco Diagnostics, Inc

Investigators

Study Director: Gianpaolo Pirovano, MD, Bracco Dianostics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)