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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Inha University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Inha University Hospital
ClinicalTrials.gov Identifier:
NCT01764438
First received: January 1, 2013
Last updated: January 3, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Procedure: Primovist-enhanced MRI

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Inha University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhancecd MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764438

Contacts
Contact: Young-Joo Jin, M.D 82-32-890-2548 jyj412@hanmail.net

Locations
Korea, Republic of
Jin-Woo Lee Recruiting
Incheon, Korea, Republic of
Contact: Jin-Woo Lee, M.D.    82-32-8902548    jin@inha.ac.kr   
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.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Inha University Hospital
ClinicalTrials.gov Identifier: NCT01764438     History of Changes
Other Study ID Numbers: INBU study, INBU study group
Study First Received: January 1, 2013
Last Updated: January 3, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Gadolinium ethoxybenzyl DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014