Subjects with confirmed or highly suspected brain tumor(s) (primary or secondary) MedDRA version: 9.1 Level: LLT Classification code 10029818
Conditions
Interventions
Trade Name: MULTIHANCE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobenic acid
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: equal
Concentration number:
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who 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. 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: Subjects who: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is: 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);Secondary Objective: The secondary objectives for this study are: - To compare the two different investigational products, 0.1 mmol/kg MULTIHANCE and 0.1 mmol/kg GADOVIST, in terms of by-subject global diagnostic preference between exams in the following secondary endpoints Border delineation of lesions Contrast enhancement of lesions Lesion Internal Morphology Extent of Disease - To compare the two different investigational products, 0.1 mmol/kg MULTIHANCE and 0.1 mmol/kg GADOVIST, in terms of changes from predose to postdose for the following quantitative parameters (signal intensity characteristics): Lesion-to-background (brain) ratio (LBR) by lesion Contrast-to-noise ratio (CNR) by lesion Lesion signal intensity enhancement;Primary end point(s): comparing images acquired with MultiHance and images acquired with Gadovist will be determined the Global diagnostic preference (primary endpoint) obtained in a paired global assessment | — |
Countries
Czech Republic, Italy
Outcome results
None listed