Intervertebral disc herniation MedDRA version: 8.1 Level: LLT Classification code 10048856 Term: Intervertebral disc herniation
Conditions
Sponsors
Bracco Imaging Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the contrasting behavior of MultiHance® and Omniscan® with regard to: · Signal intensity enhancement in disk, herniated disk, scar and other soft tissue ;Secondary Objective: · 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.;Primary end point(s): Signal intensity enhancement in disk, herniated disk, scar and other soft tissue | — |
Countries
Germany, Italy
Outcome results
None listed