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Contrast Agent
Liver MRI with EcGd and with Gdfos for Liver Tumors
N/A
Waitlist Available
Led By Laurent Milot, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will receive both gdfos and ecgd study within 4 weeks of each other. radiologist reading for the study will be done up to 52 weeks after first mri has been performed.
Awards & highlights
Study Summary
The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver metastases compared to the standard agent gadobutrol (EcGd, Gadovist).
Eligible Conditions
- Liver Tumors
- Cancer
- Metastasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants will receive both gdfos and ecgd study within 4 weeks of each other. radiologist reading for the study will be done up to 52 weeks after first mri has been performed.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will receive both gdfos and ecgd study within 4 weeks of each other. radiologist reading for the study will be done up to 52 weeks after first mri has been performed.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard
Secondary outcome measures
Inter-reader variability for EcGd-enhanced vs. Gdfos-enhanced imaging
Reader diagnostic accuracy of EcGd-enhanced imaging vs. Gdfos-enhanced imaging compared to gold standard (subgroup analysis for small lesions less than or equal to 1cm)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Liver MRI with EcGd and with GdfosExperimental Treatment2 Interventions
All participants will receive two contrast-enhanced MRI studies of the liver: one with gadofosveset trisodium (Gdfos) and one with gadobutrol (EcGd) at a dose of 0.1 mL/kg body mass up to 10 mL.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,157 Total Patients Enrolled
Laurent Milot, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
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