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CompletedNCT00486473DETECTUpdated Jul 15, 2010

Multihance Versus Magnevist in Breast MRI

A Phase 3 interventional study of Multihance and Magnevist in Breast Cancer, sponsored by Bracco Diagnostics, Inc. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-15.

Sponsored by Bracco Diagnostics, Inc · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Breast Cancer
03

In context

Lead sponsor

Bracco Diagnostics, Inc is the lead sponsor of 48 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
130 participants (estimated)

Interventions

  • DrugMultihance

    0.5 Molar at a single dose injection

  • DrugMagnevist

    0.5M at a single dose injection

06

What researchers measure

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

07

Study locations

1 site
  • Rome, Italy
08

References and documents

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. PubMed 21163915 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00486473
Lead sponsor
Bracco Diagnostics, Inc
First posted
Jun 14, 2007
Start date
Jul 2007
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jul 15, 2010

Study contacts

Gianpaolo Pirovano, MD
study director · Bracco Dianostics, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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