A Multicenter, Prospective, Non-Comparative, Non-Randomized, Open Label, Phase IV clinical trial to evaluate safety and efficacy of ProHance in patients undergoing Contrast Enhanced Magnetic Resonance Imaging (CE-MRI) of brain/spine and head and neck during routine clinical 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: 2021年11月24日

试验速览

暂无简介。

•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 CE-MRI:
•3.1 Subjects >= 2 years of age: CE-MRI for Brain (intracranial), Spine and Associated tissues
•3.2 Subjects >= 18 years of age: CE-MRI for Head and Neck

•Exclusion Criteria:
•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