Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following: clinical/neurological symptomatology
Conditions
Interventions
Trade Name: ProHance
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOTERIDOL
CAS Number: 120066-54-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Co
Sponsors
Bracco Imaging S.p.A.
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 of brain disease likely to enhance as determined by the following: • clinical/neurological symptomatology; • diagnostic testing, such as CT or previous MRI examinations; or • have had previous brain surgery 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
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 ?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; see Appendix A) • 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 or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product. • Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 45 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 |
|---|---|
| Main Objective: The primary objective for this study is to show non-inferiority of a 0.1 mmol/kg dose of PROHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams.;Secondary Objective: a)To compare the two different investigational products, 0.1 mmol/kg PROHANCE and 0.1 mmol/kg GADOVIST/GADAVIST, 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 b)To compare the two different investigational products 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 c)To compare the two different investigational products using the final clinical on-site diagnosis from all available clinical and imaging data as the reference standard in terms of the accuracy of the MR diagnosis of brain disease;Primary end point(s): Non-inferiority of ProHance compared to Gadovist in the diagnosis of MR examination in brain diseases.;Timepoint(s) of evaluation of this end point: 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Border delineation of lesions • Contrast enhancement of lesions • Lesion Internal Morphology • Extent of Disease • Lesion-to-background (brain) ratio (LBR) by lesion • Contrast-to-noise ratio (CNR) by lesion • Lesion signal intensity enhancement;Timepoint(s) of evaluation of this end point: 2 days | — |
Countries
Czech Republic, Italy, United States
Contacts
Public ContactValeria De Tullio
Bracco Imaging S.p.A.
Outcome results
None listed