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

NCT03342677 | Unknown

• 1 other identifier: UHN12-5803
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Cirrhosis; HCC; Primovist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Single Arm

OTHER

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

Interventions

Primovist MRI DIAGNOSTIC_TEST

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 36841796 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kartik Jhaveri, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Razzaz

CONTACT

4169464501; maryam.razzaz@uhn.ca

Hamideh Ale ali

CONTACT

4169464501; hamideh.aleali@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 17, 2017
• Study Start: November 7, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

CA (1)