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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Monitoring Adverse Events. Safety monitoring will begin at the time of signing the Informed Consent Form and ends up to 30 minutes following completion of the MRI examination
研究概览
简要总结
The purpose of this Phase IV post-marketing study is to evaluate and provide information related to safety and efficacy of ProHance in patients undergoing CE-MRI for brain/spine and head and neck with ProHance in routine clinical practice to Drug Controller General-India (DCGI) to meet national regulatory requirements for therapeutic product registration.
Completion of all study related procedures will take a maximum of 1 day for each subject. Study participation will begin at the time the subject signs informed consent, which can be done up to 24 Hours prior to the MRI procedure taking place.
The MRI procedure will take approximately 40 minutes.
Safety monitoring will begin at the time of signing the Informed Consent Form and ends up to 30 minutes following completion of the MRI examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Provides written Informed Consent and is willing to comply with protocol requirements;
- •Is male or female of at least 2 years of age;
- •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.
排除标准
- •Exclusion Criteria:
- •Is a pregnant or lactating female.
- •Exclude the possibility of pregnancy: 1.1 by testing on site at the institution (serum or urine βHCG) 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;
- •Has any known allergy to one or more of the ingredients of the investigational product or has a history of hypersensitivity to any metals;
- •Has received or scheduled to receive an investigational compound within 30 days before admission into this study;
- •Has severe renal impairment, defined as GFR/eGFR < 30 ml/min/1.73m2
- •Has previously entered this study;
- •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;
- •Is suffering from severe claustrophobia;
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objective, or completing the study.
结局指标
主要结局
Monitoring Adverse Events. Safety monitoring will begin at the time of signing the Informed Consent Form and ends up to 30 minutes following completion of the MRI examination
时间窗: Upto 30 minutes following completion of the MRI examination
次要结局
- Diagnosis: Normal’ or ‘Abnormal’ MRI scan.(Diagnostic gain due to Contrast agent:)