Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance® with Magnevist® in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast (DETECT) - DETECT

Bracco Imaging S.p.A.0 sites130 target enrollmentApril 2, 2007

Overview

No summary available.

Registry

who.int

Start Date

April 2, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Written Informed Consent and willingness to comply with protocol requirements/ Female of 18 years of age or older/ At least one suspicious or known breast lesion based on mammography (ACR BI\-RADS category 3, 4 or 5 lesions) and/or ultrasonography (ACR BI\-RADS category 3, 4 or 5 lesions) performed within 30 days prior to examination 1/ Planned to undergo histological diagnosis of the breast lesion(s) by non\-surgical breast biopsy (including core needle biopsy, vacuum\-assisted biopsy or large core biopsy) within 14 days but not less than 2 hours after examination 2; and/or breast surgery (including surgical biopsy, lumpectomy and mastectomy) within 30 days but not less than 24 hours after examination 2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•Body weight \>100 Kg/ Pregnant or lactating/ Severe or end\-stage organ failure, including but not limited to congestive heart failure (NYHA class IV)/ Moderate to severe renal impairment defined as having GFR/eGFR \< 60 mL/min/ Is undergoing radiotherapy or has undergone and terminated radiotherapy in the breast of interest within 18 months before examination 1/ Is undergoing chemotherapy or antitumoral hormonal therapy, or has undergone and terminated chemotherapy or antitumoral hormonal therapy within 6 months before examination 1/ History of breast surgery (including surgical biopsy, lumpectomy and mastectomy) for malignant lesion(s) within 2 years before examination 1 and for benign lesion(s) within 1 year before examination 1/ Has received or scheduled to receive any other contrast medium within 24 hours before through 24 hours after each IP injection for both, examination 1 and examination 2/ Has previously been entered into this study or has received an investigational drug within 30 days prior to examination 1/ Has pacemakers, metallic cardiac valves, other magnetic material or any other conditions that would preclude proximity to a strong magnetic field/ Suffers from severe claustrophobia/ Has known allergy to one or more of the ingredients of the investigational products or has a history of hypersensitivity to any metals and/or chelates of gadolinium