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临床试验/EUCTR2008-003669-24-DE
EUCTR2008-003669-24-DE进行中(未招募)不适用

Intra-individual cross-over comparison of MultiHance® and Vasovist® enhanced MRA of the Carotids - Vasovist MRA of the Carotids

Deutsches Krebsforschungszentrum0 个研究点开始时间: 2008年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.Adult patients, age 18-85 years
  • 2.At least one at least 90% carotid artery stenosis (confirmed by diagnostic imaging; e.g., Doppler ultrasound, MRA, CT angiography)
  • 3.Willing to undergo all study MRA procedures
  • 4.i.a. DSA of the stenosed carotid artery performed for clinical reasons within 30 days of study inclusion, or i.a. DSA planned for clinical reasons within 30 days of study inclusion
  • 5.Willing to comply with all study procedures (e.g., being interviewed at the end of the adverse event monitoring period 2 hours after the Vasovist? injection)
  • 6.Has voluntarily given written informed consent
  • 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

排除标准

  • 1.1.Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of the investigational contrast agent. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.
  • 2.Patients who are scheduled for any therapy between any of the study procedures that may interfere with the comparability of the angiographic procedures.
  • 3.Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
  • 4.Having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
  • 5.GFR <60ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 1 week before MR contrast agent injection, or patients on hemodialysis.
  • 6.Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF).
  • 7.Patients with known severe cardiac arrhythmia.
  • 8.MR contraindications (pacemaker, magnetic clips, severe claustrophobia).
  • 9.Known allergy to Gadofosveset or Gadobenate.
  • 10.Subjects presenting with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
  • 11.Having received any investigational drug within 7 days prior to entering this study or who are planned to receive any investigational drug during the 2 hours adverse event monitoring period.
  • 12.Not being able to remain lying down for at least 30-45min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
  • 13.Being clinically unstable and whose clinical course during the 2 hours adverse event monitoring period is unpredictable.
  • 14.Being scheduled for, or likely to require, any surgical intervention within 2 hours before or within the adverse event monitoring period.
  • 15.Close affiliation with the investigational site; e.g. a close relative of the investigator.
  • 16.Participating in another clinical trial.
  • 17.Having been previously enrolled in this clinical trial.

研究者

发起方
Deutsches Krebsforschungszentrum

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