Status:
UNKNOWN
Evaluation of Gd-EOB-DTPA MRI for Detection and Characterization of Liver Nodules in Cirrhotic Patients Undergoing Liver Transplantation and Potential Impact on Transplant Eligibility
Lead Sponsor:
University Health Network, Toronto
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic liver disease including cirrhosis is one of the most important factors in the multi-step progression of hepatocarcinogenesis, from benign regenerative nodules to early hepatocellular carcinoma...
Eligibility Criteria
Inclusion
- a. Patients with liver cirrhosis enlisted for liver transplantation with high probability of undergoing transplantation within the ensuing 12 months
- b. Patients who are diagnosed or suspected with HCC and listed for liver transplant surgery with priority MELD (Model for End-Stage Liver Disease) points based on the cancer diagnosis, regardless of whether they have or have not received pre-transplant treatments (incl. RFA, TACE, and XRT)
- c. Subjects must be able to undergo MRI
Exclusion
- a. GFR \<30 mL/min/1.73 m2
- b. Elevated bilirubin (\>3mg/dl)
- c. Pregnant and/or nursing women
- d. Contraindications to MRI such as pacemaker or ferromagnetic implants
- e. Hypersensitivity to Primovist or to any ingredient in the formulation or component of the container
- f. Younger than 18 years of age
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03342677
Start Date
November 7 2017
End Date
December 31 2021
Last Update
April 19 2021
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 1Z5