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OpenTrials
Completed

NCT Number: NCT00486473

Multihance Versus Magnevist in Breast MRI

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

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multihance

Drug

0.5 Molar at a single dose injection

Magnevist

Drug

0.5M at a single dose injection

Primary outcomes

  1. Sensitivity in diagnosing breast lesions compared to histopathology results

    Time frame: up to 6 months

Secondary outcomes

  1. Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

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

Acronym: DETECT

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 14, 2007
Registry last updated
Jul 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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