Liver MRI with EcGd and with Gdfos for Liver Cancer

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

No Placebo-Only Group

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

Metastasis
Liver Cancer
Liver Tumors
Cancer

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard

Secondary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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