Brain Lesions Clinical Trial
— MERITOfficial title:
Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | July 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences Corporation | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Bracco Diagnostics, Inc |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01254500 -
To Investigate the Event Related Potentials (ERPs) of Patients With Brain Lesions
|
N/A | |
Completed |
NCT01304576 -
Orientation Agnosia: Clinical and Anatomical Study
|
N/A | |
Terminated |
NCT02187822 -
Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases
|
Phase 1 | |
Withdrawn |
NCT02328300 -
FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions
|
||
Recruiting |
NCT01849549 -
Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage
|
N/A | |
Completed |
NCT02559401 -
Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation
|
||
Completed |
NCT03528200 -
DYNA EMBOLIZATION - Pilot Study of IV Dyna CT and CBV Imaging Techniques
|
N/A |