Multi-center, Double-blind, Randomized, Controlled, Parallel Group, Dose Comparison Study With Corresponding Blinded Image Evaluation Following a Single Intravenous Injection of Three Different Doses of Gadobutrol 1.0 Molar (Gadavist) in Patients With Known or Suspected Focal Blood Brain Barrier Disturbances and/or Abnormal Vascularity of the Central Nervous System

Bayer27 个研究点分布在 4 个国家目标入组 237 人开始时间: 2005年8月最近更新: 2014年1月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Bayer
入组人数: 237
试验地点: 27
主要终点: Categorical Visualization Score (CVS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

详细描述

Safety issues are addressed in the Adverse Events section

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with either known or highly suspected focal areas of disruption of the blood brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS.
•Patients with untreated brain tumors should constitute a minimum of 50% of the study population and patients with treated brain tumors will be limited to a maximum of 20% of the study population

排除标准

•Is a female patient who is pregnant or nursing.
•Is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment.
•Has received any investigational product within 30 days prior to enrolling in this study.
•Has been previously enrolled in this study or any other study using gadobutrol.
•Has any contraindication to the MRI examinations.
•Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
•Has received any contrast agent within 24 hours prior to gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study.
•Is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure).
•Has been treated with high dose (>55 cobalt Gy equivalent) photon radiation or global radiotherapy for CNS lesions at any time before entering the study.
•Is scheduled to receive chemotherapy or radiotherapy during the study period.
•Is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol MRIs that may alter their interpretation.
•Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol MRI procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies.
•Has severe cardiovascular disease.
•Has any contraindication to OptiMARK according to the package insert.
•Has more than 30 brain lesions detected by any prior imaging examination.

研究组 & 干预措施

Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

干预措施: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) (Drug)

Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

干预措施: OptiMARK~0.1 mmol/kg BW (Drug)

Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

干预措施: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) (Drug)

Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

干预措施: OptiMARK~0.1 mmol/kg BW (Drug)

Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

干预措施: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) (Drug)

Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

干预措施: OptiMARK~0.1 mmol/kg BW (Drug)