patients sent to the sites with a request for assessment/diagnoses of certain/suspected brain neoplasms MedDRA version: 6.1 Level: PT Classification code 10029816
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadodiamide
CAS Number: 131410-48-5
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical Fo
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
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 , as determined by at least one of the following clinical/neurological symptomatology; diagnostic testing, such as CT or previous MRI examinations from 30 days to 24 hours prior to the first MRI exam; 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: 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 61538;HCG within 24 hours prior to the start of each investigational product administration; or by history i.e., tubal ligation or hysterectomy ; or post menopausal with a minimum of 1 year without menses. Have any known allergy to one or more of the ingredients in the investigational products, 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 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2. Have received an investigational compound and/or medical device within 30 days before admission into the present study, and/or are scheduled to 24 hours post-administration of the second investigational product. 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 |
|---|---|
| Main Objective: 1 To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of OMNISCAN, in terms of the by-patient global diagnostic preference between exams i.e., based on predose postdose image sets .A;Secondary Objective: A2 To compare the two different investigational products, 0.1 mmol/kg MULTIHANCE and 0.1 mmol/kg OMNISCAN, in terms of by-patient global preference between exams in the following secondary endpoints Border delineation of lesions; Contrast conspicuity of lesions. 3 To compare the two different investigational products, 0.1 mmol/kg MULTIHANCE and 0.1 mmol/kg OMNISCAN, in terms of global change in lesion count between exams. 4 To compare the two different investigational products, 0.1 mmol/kg MULTIHANCE and 0.1 mmol/kg OMNISCAN, in terms of changes from predose to postdose for the following quantitative parameters signal intensity characteristics Lesion-to-background ratio LBR by lesion; Contrast-to-noise ratio CNR by lesion; Percent contrast enhancement by lesion.;Primary end point(s): The visualization efficacy endpoints of the study for the off-site assessment are the following. Unpaired reading by three independent neuroradiologists lesion count; volumetric tumor measurement. Global paired reading by the same three independent neuroradiologists degree of lesion border delineation on a seven-points relative scale ; global diagnostic preference on a seven-points relative scale ; degree of lesion contrast conspicuity on a five-points relative scale . | — |
Countries
Italy
Outcome results
None listed