Multihance Versus Magnevist in Breast MRI (DETECT)

This study has been completed.

Sponsor:

Information provided by:

Bracco Diagnostics, Inc

ClinicalTrials.gov Identifier:

NCT00486473

First received: June 13, 2007

Last updated: July 14, 2010

Last verified: July 2010

History of Changes

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: Multihance Drug: Magnevist	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Gadopentetate dimeglumine Gadobenate Dimeglumine

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

Sensitivity in diagnosing breast lesions compared to histopathology results [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	July 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

0.5 Molar at a single dose injection

0.5M at a single dose injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486473

Locations

Italy

Rome, Italy

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Director:

Gianpaolo Pirovano, MD

Bracco Dianostics, Inc.

More Information

No publications provided by Bracco Diagnostics, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Dec 16.

Responsible Party:	Gianpaolo Pirovano, M.D., Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc.
ClinicalTrials.gov Identifier:	NCT00486473 History of Changes
Other Study ID Numbers:	MH 131
Study First Received:	June 13, 2007
Last Updated:	July 14, 2010
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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