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 - ND
- Conditions
- Probable lumbo sacral disk reherniationMedDRA version: 9.1Level: LLTClassification code 10039541Term: Scan NOS bone normal
- Registration Number
- EUCTR2006-001979-38-IT
- Lead Sponsor
- Bracco Imaging Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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
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 contrast 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Quantitative evaluations.;Primary end point(s): Quality of delineation between scar and herniated disk tissue Confidence in differential diagnosis scar - herniated disk tissue;Main Objective: Objectives of the present study are to compare the contrasting behavior of MultiHance and Omniscan with regard to: Signal intensity enhancement in disk, herniated disk, scar and other soft tissue; The contrast between the different tissue types; The qualitative assessment of delineation between scar and herniated tissue The qualitative assessment of the confidence in differential diagnosis between scar and herniated tissue.
- Secondary Outcome Measures
Name Time Method