Brain Lesions
Conditions
Brief summary
This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.
Interventions
DRUGMULTIHANCE:
MULTIHANCE ® 0.5 M,0.1 mmol/kg
DRUGGADOVIST
GADOVIST ® 1.0 M,0.1 mmol/kg
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enroll subjects in this study if they meet the following inclusion criteria: * Are at least 18 years of age or older * Are able to give written informed consent and are willing to comply with the protocol requirements * Are scheduled to undergo MRI * Are willing to undergo two MRI procedures within 14 days * Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by: * clinical/neurological symptomatology; * diagnostic testing, such as CT or previous MRI examinations; or * have had recent surgery within 6 months and are to be evaluated for recurrence.
Exclusion criteria
* Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed. * Are pregnant or lactating females. Exclude the possibility of pregnancy: * by testing on site at the institution (serum or urine bHCG) within 24 h prior to the start of each investigational product administration * by history (i.e., tubal ligation or hysterectomy) * post menopausal with a minimum of 1 year without menses * Have any known allergy to one or more of the ingredients in the investigational product, or have a history of hypersensitivity to any metals * 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 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2 * 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 24 h post-administration of the second investigational product. * Have moderate-to-severe renal impairment, defined as a GFR/eGFR \< 60 mL/min. * Have been previously entered into this study * Have received or are scheduled for one of the following: * Surgery within three weeks prior to the first examination or between the two examinations * Initiation of steroid therapy between the two examinations * Radiosurgery between the two examinations * Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field. * Are suffering from severe claustrophobia * Have 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets). | Day 1 and Day 2 |
Countries
Canada
Outcome results
None listed