Intracraniële laesies verwezen voor contrastverbeterde MRI van de hersenen contrast medium intracranial lesions
Conditions
Interventions
All patients will have their scheduled contrast enhanced MRI with Gadovist®.
Gadovist® will be injected at the dose of 0.1 mmol Gd/Kg corresponding to 0.1
mL/Kg as per prescribing information.
At l
the study
will start with the lowest dose group (i.e., 0.025 mmol Gd/kg). Between each
consecutive dose group there will be an interval of time sufficient for
reviewing the safety data. The volume
Sponsors
Bracco Imaging S.pA.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Provides written Informed Consent and is willing to comply with protocol requirements; • Male and female between 18 and 75 years of age inclusive; • Is referred for and has been scheduled to undergo a contrast-enhanced MRI examination of the brain; • Has a Karnofsky Performance Score >=70.
Exclusion criteria
Exclusion criteria: • Is a pregnant or lactating female. Exclude the possibility of pregnancy: • by testing on site at the institution (serum βHCG) within 24 hours prior to the start of Gadovist(r) administration, • by surgical history (e.g., tubal ligation or hysterectomy), • post-menopausal with a minimum 1 year without menses; • Has any known allergy to GBCAs; • Have congestive heart failure (class IV according to the classification of the New York Heart Association;); • Have suffered a stroke within a year; • Have received or are scheduled to receive any other contrast medium in the 24 hours preceding Gadovist(r) injection through 7 days following B26826 administration; • Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 7 days post-administration of B26826; • Suffers from mild-to-severe chronic kidney disease (estimated glomerular filtration rate < 60 mL/min/1.73 m2 calculating using the abbreviated MDRD formula); • Has, in the previous 7 days before the first MRI with Gadovist® (0.1 mmolGd/kg) through B26826 administration, received prescription or non-prescription systemic medications (e.g., anticancer drugs, barbiturates, or phenothiazines) which, in the opinion of the Investigator, may interfere with the study procedure or affect safety and efficacy assessments; • Has received or are scheduled for one of the following: • Surgical, radiation or chemotherapeutic treatment within one weeks prior to the first examination or between the two examinations; • initiation of steroid therapy between the two examinations; • Has any contraindications to MRI such as a pacemaker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field • Are suffering from severe claustrophobia; • Has participated in a clinical trial of an investigational drug and/or medical device within 3 months before admission into this study; • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations; • Cannot reliably communicate with the Investigator or is not likely to co-operate with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To determine the safety, - To investigate the pharmacokinetics (PK), and - To obtain pilot efficacy data | — |
Countries
Netherlands
Outcome results
None listed