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

NCT ID: NCT03342677

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2021-12-31

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 carcinomas (HCCs) and finally to overt HCCs. Early diagnosis of HCC, differentiation from benign hepatocellular nodules, and surgical resection of the tumor or transplantation of the liver provide the best chance for long-term survival. Several studies have evaluated MRI enhanced with superparamagnetic iron oxide, gadolinium-based contrast material, or both, for the detection and differential diagnosis of focal hepatic lesions. However, the differentiation of HCC from benign and or borderline hepatocellular nodules remains difficult, particularly in patients with cirrhosis, because of the architectural distortion of liver parenchyma and the development of cirrhotic nodules, ranging from benign regenerative nodules to overt HCC, with overlapping imaging features. Recently, gadoxetic acid (gadoliniumethoxybezyl-diethylenetriamine pentaacetic acid; Primovist®, Bayer Health Care Pharmaceuticals), a gadolinium-based paramagnetic contrast agent that produces both dynamic and liver-specific hepatobiliary MRI studies has gained widespread use. Some studies have showed that gadoxetic acid-enhanced MRI allows the accurate detection and characterization of HCC. Investigators plan to assess this in particular as it is a question of great relevance. Execution of well conducted prospective studies will also clarify inclusion of Gd-EOB-DTPA enhanced MRI as the technique of choice in evaluation of patients at risk for HCC.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single Arm

In this project, there is only one study group which comprises of patients with Hepatocellular Carcinoma (HCC) who will undergo Liver MRI with Primovist before hepatic transplantation.

Group Type: OTHER

Primovist MRI

Intervention Type: DIAGNOSTIC_TEST

Utility of Gd-EOB-DTPA (Primovist) enhanced Liver MRI in HCC detection and characterization in cirrhotic patients will be studied.

Interventions

Primovist MRI

Utility of Gd-EOB-DTPA (Primovist) enhanced Liver MRI in HCC detection and characterization in cirrhotic patients will be studied.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kartik Jhaveri, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Maryam Razzaz

Role: CONTACT

maryam.razzaz@uhn.ca

4169464501 ext. 5734

Hamideh Ale ali

Role: CONTACT

hamideh.aleali@uhn.ca

4169464501 ext. 5729

Facility Contacts

Maryam Razzaz

Role: primary

maryam.razzaz@uhn.ca

4169464501 ext. 5734

References

Jhaveri KS, Babaei Jandaghi A, Bhayana R, Elbanna KY, Espin-Garcia O, Fischer SE, Ghanekar A, Sapisochin G. Prospective evaluation of Gadoxetate-enhanced magnetic resonance imaging and computed tomography for hepatocellular carcinoma detection and transplant eligibility assessment with explant histopathology correlation. Cancer Imaging. 2023 Feb 25;23(1):22. doi: 10.1186/s40644-023-00532-3.

Reference Type: DERIVED

PMID: 36841796 (View on PubMed)

Other Identifiers

UHN12-5803

Identifier Type: -

Identifier Source: org_study_id