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 个研究点目标入组 130 人开始时间: 2007年3月28日最近更新: 2013年3月25日

试验速览

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•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

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