Multihance Versus Magnevist in Breast MRI (DETECT)

Bracco

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Magnevist; Drug: Multihance

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486473

MH 131

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind