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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT03342677

Collaborator

(none)

Enrollment

Location

Arm

49.8

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Diagnostic Test: Primovist MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 7, 2017

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Diagnostic Test: Primovist MRI Utility of Gd-EOB-DTPA (Primovist) enhanced Liver MRI in HCC detection and characterization in cirrhotic patients will be studied.

Arm

Intervention/Treatment

Other: 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.

Diagnostic Test: Primovist MRI

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

Outcome Measures

Primary Outcome Measures

Comparison of Gd-EOB-DTPA enhanced liver MRI and CT scan images in characterizing cirrhotic nodules and HCC in liver transplant candidates [26 months]

Secondary Outcome Measures

Investigation of Gd-EOB-DTPA enhanced MRI efficacy in diagnosis and staging of HCC in cirrhotic patients and its potential impact on liver transplantation eligibility in patients who are liver transplant candidates [26 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Patients with liver cirrhosis enlisted for liver transplantation with high probability of undergoing transplantation within the ensuing 12 months

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)
Subjects must be able to undergo MRI

Exclusion Criteria:

1. GFR <30 mL/min/1.73 m2

Elevated bilirubin (>3mg/dl)
Pregnant and/or nursing women
Contraindications to MRI such as pacemaker or ferromagnetic implants
Hypersensitivity to Primovist or to any ingredient in the formulation or component of the container
Younger than 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network	Toronto	Ontario	Canada	M5G 1Z5

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Kartik Jhaveri, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03342677

Other Study ID Numbers:

UHN12-5803

First Posted:

Nov 17, 2017

Last Update Posted:

Apr 19, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Health Network, Toronto

Cirrhosis

HCC

Primovist

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Apr 19, 2021