Utility Study of Primovist-MRI on HCC Staging (PrimovistMRI)

January 3, 2013 updated by: Inha University Hospital

The Incidence of Change in BCLC Stage by add-on Primovist-enhanced MRI During Initial Staging Work-up in HCC Patients Who Can be Candidates for Curative Treatment by Liver Dynamic CT: A Prospective Multicenter Study

Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhanced MRI can affect on BCLC staging during the initial staging workups of definite HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer related death worldwide, and its incidence continues to rise even in the Europe and the United States. Recent advancements in early diagnosis and treatment modalities have significantly improved survival in HCC patients, but, only a small portion of them can receive curative treatments. Treatment decision making in HCC is guided by tumor stage, which can be also affected by tumor status at presentation.Thus, intrahepatic tumor status can be pivotal for treatment decision making and for determining prognosis in HCC patients, especially in possible candidates for curative treatment.

The current AASLD guideline recommends that HCC patients with typical HCC ≥1 cm by liver dynamic computed tomography (CT) do not require further investigation to confirm the presence of HCC, and that appropriate treatment can be initiated based on tumor stage. However, other intrahepatic HCC lesion which is not detected by liver dynamic CT can be additionally detected only by Primovist-enhanced MRI.Although few studies have evaluated the usefulness of Primovist-enhanced MRI in HCC patients,most of these studies have been limited by the lack of an evaluation of shift in HCC stage and by the inclusion of patients with suspicious intrahepatic HCC lesions that had been already detected by liver dynamic CT. Furthermore, given the poor prognosis of HCC patients with recurrence after curative treatments such as liver transplantation, surgical resection, or radiofrequency ablation (RFA),accurate staging workup is essential for intrahepatic HCC, especially in patients with a very early or early Barcelona Clinic Liver Cancer (BCLC) staged HCC. To date, however, no evidence based recommendations have been made regarding the benefit of add-on examination of Primovist-enhanced MRI during initial staging workups in HCC patients who are candidates for curative treatment after diagnosis by liver dynamic CT.

In this prospective multicenter study, therefore, we will assess the usefulness of Primovist-enhanced MRI during the initial staging workups of HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT. We will examine whether Primovist-enhanced MRI could provide additional information on BCLC stage, by directly comparing to liver dynamic CT in these patients. Furthermore, we assess whether add-on Primovist-enhanced MRI after a diagnosis of HCC by liver dynamic CT could aid treatment decision making in these patients.

Study Type

Observational

Enrollment (Anticipated)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Recruiting
        • Jin-Woo Lee
        • Contact:
        • Principal Investigator:
          • Young-Joo Jin, M.D.
        • Principal Investigator:
          • Jin-Woo Lee, M.D.
        • Sub-Investigator:
          • Jung-il Lee, D.M.
        • Sub-Investigator:
          • Oh Sang Kwon, M.D
        • Sub-Investigator:
          • Young Kul Jung, M.D
        • Sub-Investigator:
          • Young-Suk Kim, M.D.
        • Sub-Investigator:
          • Tae Hun Kim, M.D.
        • Sub-Investigator:
          • Jeong Won Jang, M.D.
        • Sub-Investigator:
          • Jung Hyun Kwon, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HCC patients with very early (BCCLC stage 0) or early (BCLC stage A) stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT

Description

Inclusion Criteria:

  • 18 years ≤ age
  • Patients who are initially diagnosed as having hepatocellular carcinoma with very early or early BCLC stage by liver dynamic CT at each hospital
  • Performance status 0 or 1
  • Child-Turcotte-Pugh score ≤8

Exclusion Criteria:

  • Age of younger than 18
  • Patients with any concurrent cancer other than hepatocellular carcinoma. Any cancer curatively treated at least 3 years prior to entry is permitted.
  • Patients with BCLC B, C, or D staged HCC at initial diagnosis by liver dynamic CT
  • Patients with suspicious intrahepatic malignant lesion by liver dynamic CT
  • Patients with HIV infection
  • Female patients in pregnancy
  • Clinically hemodyanmically unstable patients
  • Patients with previous life-threatening anaphylactic reaction to contrast media
  • Patients scheduled for biopsy or liver surgery within 24 h post-administration of the study
  • Patients who cannot underwent CT due to renal insufficiency (estimated GFR < 30 mL/min/1.73m2)
  • Patients who cannot perform MRI due to contraindication of MRI (e.g. an implanted cardiac pacemaker)
  • Patients in whom MRI was performed before liver dynamic CT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
very early or early staged patients
Performance of Primovist-enhanced MRI in HCC patients with very early or early stage disease, but with no suspicious HCC by liver dynamic CT
Procedure: Primovist-enhanced MRI
Performance of Primovist-enhanced MRI in HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT.
Other Names:
  • Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhancecd MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of change of BCLC stage after add-on Primovist-enhanced MRI in HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT.
Time Frame: Performance of Primovist enhanced MRI within the first 7 days after liver dynamic CT
Performance of Primovist enhanced MRI within the first 7 days after liver dynamic CT

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of newly detected intrahepatic HCC lesionss by Primovist-enhanced MRI, but, these lesions were not detected by liver dynamic CT
Time Frame: Performance of Primovist-enhacned MRI within 7 days after liver dynamic CT
Performance of Primovist-enhacned MRI within 7 days after liver dynamic CT
Incidence of newly detected intrahepatic benign lesions by Primovist-enhanced MRI, but, these lesions were not detected by liver dynamic CT
Time Frame: Performance of Primovist-enhanced MRI within 7 days after liver dynamic CT
Performance of Primovist-enhanced MRI within 7 days after liver dynamic CT
Frequency of change in treatment modality in patients with change of BCLC stage after Primovist-enhanced MRI
Time Frame: Performance of Primovist-enhanced MRI within 7 days after liver dynamic CT
Performance of Primovist-enhanced MRI within 7 days after liver dynamic CT
Sensitivity, specificity, false positive predictive value, false negative predictive value, and accuracy of Primovist-enhanced MRI
Time Frame: after performance of Primovist-enhanced MRI and liver dynamic CT
after performance of Primovist-enhanced MRI and liver dynamic CT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Investigators

  • Principal Investigator: Jin-Woo Lee, M.D., Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Repubulic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

January 1, 2013

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INBU study
  • INBU study group (Registry Identifier: INBU group for the study of the liver)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Primovist-enhanced MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe