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

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

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

No

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

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)

December 1, 2009

Study Registration Dates

First Submitted

June 13, 2007

First Submitted That Met QC Criteria

June 13, 2007

First Posted (Estimate)

June 14, 2007

Study Record Updates

Last Update Posted (Estimate)

July 15, 2010

Last Update Submitted That Met QC Criteria

July 14, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • MH 131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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