Ignite Creation Date:
2024-05-06 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01764438
Status:
UNKNOWN
Last Update Posted:
2013-01-09
First Post:
2013-01-01
Brief Title:
Utility Study of Primovist-MRI on HCC Staging
Sponsor:
Inha University Hospital
Organization:
Inha University Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrimovistMRI
Brief Summary:
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
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 presentationThus 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 MRIAlthough few studies have evaluated the usefulness of Primovist-enhanced MRI in HCC patientsmost 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 RFAaccurate 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
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 MRIAlthough few studies have evaluated the usefulness of Primovist-enhanced MRI in HCC patientsmost 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 RFAaccurate 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| INBU study group | REGISTRY | INBU group for the study of the liver | None |