Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05486572
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2022-08-01
Brief Title:
Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs MRI
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs MRI The PREMIUM Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
PREMIUM
Brief Summary:
The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC aMRI AFP to the standard-of-care screening USAFP in patients at high risk of developing HCC The investigators hypothesize that HCC will be detected at earlier stages allowing for more curative treatments and resulting in a reduction in HCC-related mortality
Detailed Description:
Study Design The investigators propose to conduct a randomized controlled trial of screening for hepatocellular carcinoma HCC by ultrasound USserum alpha fetoprotein AFP every 6 months the current standard-of-care versus abbreviated MRI aMRIAFP every 6 months among patients with cirrhosis who have a high risk of HCC estimated annual HCC risk 25
Study Population Patients ages 18-75 with cirrhosis standard histologic radiologic or clinical criteria of any etiology with estimated annual HCC risk 25 Exclusion Criteria Prior HCC Child C Cirrhosis CTP score 10 MELD score 20 Listed for liver transplantation Contra-indications to MRI Comorbidities with limited life expectancy defined by a cirrhosis-specific comorbidity index CirCom score 3
Study Setting 47 VA Medical Centers will recruit on average 100 patientssite over 3 years These recruitment sites which have already been identified have adequate numbers of cirrhosis patients eligible for screening a qualified hepatologist and radiologist to serve as local site investigators LSIs adequate MRI and US capacity and access to a multidisciplinary liver tumor board MLTB
Target Sample Size N2350 per group total N4700
Randomization The randomization scheme will be random permuted with variable block size and will be stratified by medical center and MELD score
Intervention Participants will be randomized in a 11 ratio to one of two screening arms
a Abdominal aMRI serum AFP every 6 months OR b Abdominal US serum AFP every 6 months from the time of recruitment until the end of study Year 8
The aMRI protocol will include only T1-weighted pre-contrast and dynamic contrast-enhanced images utilizing an extracellular gadolinium-based contrast agent aMRI takes only 15 minutes to perform Enrollment will occur in Years 1-3 screening per protocol will continue through Year 8 and follow-up for mortality will continue through Year 8 Analysis and publication will be in Year 9
Primary Outcome HCC-related mortality
Power Calculations The study is powered to detect a minimum relative reduction in HCC-related mortality of 35 in the aMRIAFP arm compared to the USAFP arm ie a reduction in cumulative HCC-related mortality at Year 8 from 71 per 100 patients in the USAFP arm to 46 per 100 patients in the aMRIAFP arm absolute difference in HCC-related mortality of 25 per 100 patients adjusted for dropout due to death from other causes or withdrawals with power 88 and two-sided alpha 005
Study Population Patients ages 18-75 with cirrhosis standard histologic radiologic or clinical criteria of any etiology with estimated annual HCC risk 25 Exclusion Criteria Prior HCC Child C Cirrhosis CTP score 10 MELD score 20 Listed for liver transplantation Contra-indications to MRI Comorbidities with limited life expectancy defined by a cirrhosis-specific comorbidity index CirCom score 3
Study Setting 47 VA Medical Centers will recruit on average 100 patientssite over 3 years These recruitment sites which have already been identified have adequate numbers of cirrhosis patients eligible for screening a qualified hepatologist and radiologist to serve as local site investigators LSIs adequate MRI and US capacity and access to a multidisciplinary liver tumor board MLTB
Target Sample Size N2350 per group total N4700
Randomization The randomization scheme will be random permuted with variable block size and will be stratified by medical center and MELD score
Intervention Participants will be randomized in a 11 ratio to one of two screening arms
a Abdominal aMRI serum AFP every 6 months OR b Abdominal US serum AFP every 6 months from the time of recruitment until the end of study Year 8
The aMRI protocol will include only T1-weighted pre-contrast and dynamic contrast-enhanced images utilizing an extracellular gadolinium-based contrast agent aMRI takes only 15 minutes to perform Enrollment will occur in Years 1-3 screening per protocol will continue through Year 8 and follow-up for mortality will continue through Year 8 Analysis and publication will be in Year 9
Primary Outcome HCC-related mortality
Power Calculations The study is powered to detect a minimum relative reduction in HCC-related mortality of 35 in the aMRIAFP arm compared to the USAFP arm ie a reduction in cumulative HCC-related mortality at Year 8 from 71 per 100 patients in the USAFP arm to 46 per 100 patients in the aMRIAFP arm absolute difference in HCC-related mortality of 25 per 100 patients adjusted for dropout due to death from other causes or withdrawals with power 88 and two-sided alpha 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None