EUCTR2006-001979-38-DE进行中（未招募）不适用
INTRAINDIVIDUAL CROSS-OVER STUDY TO COMPARE MULTIHANCE® AND OMNISCAN® AT A DOSE OF 0.1 MMOL/KGBW IN THE DIFFERENTIAL DIAGNOSIS OF DISC HERNIATION VS. SCAR - MultiHance® vs. Omniscan® for Spinal Diseases
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Patient had a disk surgery at the lumbosacral spine (between 3 weeks and 12 months before enrolment into this study) and suffers from clinical symptoms suggesting recurrent symptoms;
- •2. Patient is scheduled for MRI for differential diagnosis between herniated disk and scar (soft tissue)3.Patient's age is >= 18 years old;
- •4. Patient gave written Informed Consent to participate in the study and is willing to comply with protocol requirements.
- •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. Patient has a body weight >= 150 kg;
- •2. Patients with a severe heart failure (NYHA class IV);
- •3. Patient has undergone any intravascular MR contrast agent procedure within 48 hours preceding the first MR examination;
- •4. Patient with a history of hypersensitivity to any metals or to chelates of Gadolinium or to any ingredients of the two study agents;
- •5. Patients with a significant allergic disposition;
- •6. Patient with pacemakers, ferro-magnetic material such as surgical clips or any other conditions that would preclude proximity to a strong magnetic field;
- •7. Patient is suffering from severe claustrophobia;
- •8. Patient with any medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study and/or post-imaging follow-up examinations;
- •9. Patient is female and pregnant or nursing;
- •10. Patient is female and the possibility of pregnancy cannot be excluded from one of the following points:
- •- surgical sterilization (method has to be recorded on medical history form),
- •- confirmed post-menopausal (with minimum 1-year history without menstruation),
- •- negative pregnancy test (confirmed via ß-HCG measurement);
- •11. Patient is currently participating or has previously participated in a study (in which an investigational drug was dispensed) within 30 days prior to admission to this study;
- •12. Patient has previously entered this study;
- •13. Patient without legal capacity (i.e. prisoners);
- •14. Patient has moderate to severe renal impairment defined as having GFR/eGFR
- •< 60 mL/min.
研究者
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