A Multicenter, Prospective, Non-Comparative, Non-Randomized,Open Label, Phase IV clinical trial to evaluate safety and efficacy ofProHance in patients undergoing Contrast Enhanced MagneticResonance Imaging (CE-MRI) of the whole body during routineclinical practice in India.

Bracco Diagnostics Inc0 个研究点目标入组 110 人开始时间: 待定最近更新: 2022年11月21日

试验速览

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•1 Provides written Informed Consent and is willing to comply with protocol requirements;
•2 Is male or female of at least 2 years of age;
•3 Is scheduled to undergo whole-body CE-MRI with exception of CNS and head/neck MRI.

•1.Is a pregnant or lactating female. Exclude the possibility of pregnancy:
•1.1.by testing on site at the institution (serum or urine Î²HCG) within 24 hours prior to the
•start of investigational product administration,
•1.2.by surgical history (e.g., tubal ligation or hysterectomy),
•1.3.post-menopausal with a minimum 1 year without menses;
•2.Has any known allergy to one or more of the ingredients of the investigational product or
•has a history of hypersensitivity to any metals;
•3.Has received or scheduled to receive an investigational compound within 30 days before
•admission into this study;
•4.Has severe renal impairment, defined as GFR/eGFR < 30 ml/min/1.73m2
•5.Has previously entered this study;
•6.Has any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical
•clips) or any other conditions that would preclude proximity to a strong magnetic field;
•7.Is suffering from severe claustrophobia;
•8.Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objective, or completing the study.

发起方