Comparison of Multihance and Dotarem in brain tumor(s)

• Conditions: Patients 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 brain surgery and are to be evaluated for recurrence; MedDRA version: 16.1Level: LLTClassification code 10029820Term: Nuclear magnetic resonance imaging gadolinium-enhancedSystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-003886-33-CZ
• Lead Sponsor: Bracco Imaging S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-20
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 176

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:
a) clinical/neurological symptomatology;
b) diagnostic testing, such as CT or previous MRI examinations; or
c) have had recent 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 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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:
a) by testing on site at the institution (serum or urine HCG) within 24 hours prior to the start of each investigational product administration; or
b) by history (i.e., tubal ligation or hysterectomy); or
c) 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 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:
a) surgical or chemotherapeutic treatment within three weeks prior to the first examination or between the two examinations
b) initiation of steroid therapy between the two examinations
c) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified