---
title: Multihance Versus Magnevist in Breast MRI
nct_id: NCT00486473
overall_status: COMPLETED
phase: PHASE3
sponsor: Bracco Diagnostics, Inc
study_type: INTERVENTIONAL
primary_condition: Breast Cancer
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00486473.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00486473"
ct_last_update_post_date: 2010-07-15
last_seen_at: "2026-05-12T06:19:12.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Multihance Versus Magnevist in Breast MRI

**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

**NCT ID:** [NCT00486473](https://clinicaltrials.gov/study/NCT00486473)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 130
- **Lead Sponsor:** Bracco Diagnostics, Inc
- **Conditions:** Breast Cancer
- **Start Date:** 2007-07
- **Completion Date:** 2009-12
- **CT.gov Last Update:** 2010-07-15

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **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:

* 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
```

## Interventions

- **Multihance** (DRUG) — 0.5 Molar at a single dose injection
- **Magnevist** (DRUG) — 0.5M at a single dose injection

## Primary Outcomes

- **Sensitivity in diagnosing breast lesions compared to histopathology results** _(time frame: up to 6 months)_

## Secondary Outcomes

- **Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels** _(time frame: up to 6 months)_

## Locations (1)

- Rome, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|rome||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00486473.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00486473*  
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