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Gadoxetic Acid-MRI Versus Ultrasonography for the Surveillance of Hepatocellular Carcinoma in High-risk Patients (PRIUS)

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ClinicalTrials.gov Identifier: NCT01446666
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Young-Suk Lim, Asan Medical Center

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Cirrhosis of Liver
Enrollment 423
Recruitment Details Study participants were recruited between November 2011 and August 2012. The inclusion criteria for participation were an age of 20 years or older and the presence of cirrhosis with an estimated annual HCC risk of >5%.
Pre-assignment Details The absence of hepatocellular carcinoma (HCC) had been evaluated by US, dynamic CT scan, or MRI within 6 months before enrollment. Patients with Child-Pugh class C liver function or estimated glomerular filtration rate <30 mL/min/1.73m^2 were excluded.
Arm/Group Title US+MRI
Hide Arm/Group Description The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals
Period Title: Overall Study
Started 407 [1]
Completed 326
Not Completed 81
[1]
Among the 423 participants who consented, 15 withdrew the consent and one died.
Arm/Group Title US+MRI
Hide Arm/Group Description The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals.
Overall Number of Baseline Participants 407
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 407 participants
56
(52 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 407 participants
Female
177
  43.5%
Male
230
  56.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Korean Number Analyzed 407 participants
407
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
South Korea Number Analyzed 407 participants
407
 100.0%
1.Primary Outcome
Title Detection Rate of Patients With HCC
Hide Description - The number of patients with definite HCC detected by a given modality divided by the total number of patients with definite HCC detected by any of 2 modalities plus interval cancers
Time Frame during the 1.5-year study period (from the date of first screening to 6 months following the last screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 43 patients with HCCs: 1 detected by US only, 26 by MRI only, 11 by both, and 5 were missed by both and were detected by follow-up CT scan.
Arm/Group Title Ultasonography Gadoxetic Acid-enhanced MRI
Hide Arm/Group Description:
Results from ultrasonography
Results from Gadoxetic acid-enhanced MRI
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: percentage of HCC detected on each exam
27.9 86.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultasonography, Gadoxetic Acid-enhanced MRI
Comments The HCC detection rate was defined as the number of patients with HCC detected by a given modality divided by the total number of patients with HCC detected by all modalities and by follow-up dynamic CT scan. The HCC detection rates from ultrasonography and MRI were compared.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Detection Rate of Patients With Early Stage HCC
Hide Description
  • The number of patients with early stage HCC detected by a given modality divided by the total number of patients with early stage HCC detected by any of 2 modalities plus interval cancers.
  • Early stage (stage A or 0) HCC is defined by the Barcelona Clinic Liver Cancer staging system (BCLC): A single HCC <5 cm or <=3 lesions each <3 cm in diameter, without gross vascular invasion or extrahepatic metastasis.
Time Frame during the 1.5-year study period (from the date of first screening to 6 months following the last screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 43 patients, 32 (74.4%) had very early-stage (single nodule <2 cm) and 10 (23.3%) had early-stage HCC (single 2-5 cm or 2-3 lesions each <3 cm).
Arm/Group Title Ultasonography Gadoxetic Acid-enhanced MRI
Hide Arm/Group Description:
Results from ultrasonography
Results from Gadoxetic acid-enhanced MRI
Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: percentage of early HCC detected
26.2 85.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultasonography, Gadoxetic Acid-enhanced MRI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
3.Secondary Outcome
Title Detection Rate of Patients With Very Early Stage HCC
Hide Description
  • The number of patients with HCC nodules of very early stage detected by a given modality divided by the total number of definite HCC nodules of very early stage detected by any of 2 modalities plus interval cancers.
  • Very early stage (stage 0) HCC is defined by the Barcelona Clinic Liver Cancer staging system (BCLC): A single HCC <2 cm without gross vascular invasion or extrahepatic metastasis.
Time Frame during the 1.5-year study period (from the date of first screening to 6 months following the last screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 43 patients, 32 (74.4%) had very early-stage.
Arm/Group Title Ultasonography Gadoxetic Acid-enhanced MRI
Hide Arm/Group Description:
Results from ultrasonography
Results from Gadoxetic acid-enhanced MRI
Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: percentage of detected very early HCC
27.3 84.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultasonography, Gadoxetic Acid-enhanced MRI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
4.Secondary Outcome
Title False Positive Rate
Hide Description The false-positive rate was defined as the number of tests with positive findings by a specific imaging modality in patients without a HCC.
Time Frame during the 1.5-year study period (from the date of first screening to 6 months following the last screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultasonography Gadoxetic Acid-enhanced MRI
Hide Arm/Group Description:
Results from ultrasonography
Results from Gadoxetic acid-enhanced MRI
Overall Number of Participants Analyzed 364 364
Overall Number of Units Analyzed
Type of Units Analyzed: The number of exams
1057 1057
Measure Type: Number
Unit of Measure: percentage of false positive test
5.6 3.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultasonography, Gadoxetic Acid-enhanced MRI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
5.Secondary Outcome
Title Positive Predictive Value for HCC
Hide Description The positive predictive value was the number of true positive test results in patients with the positive tests in a specific modality.
Time Frame during the 1.5-year study period (from the date of first screening to 6 months following the last screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultasonography Gadoxetic Acid-enhanced MRI
Hide Arm/Group Description:
Results from ultrasonography
Results from Gadoxetic acid-enhanced MRI
Overall Number of Participants Analyzed 71 69
Measure Type: Number
Unit of Measure: percentage of true positive calls
16.9 53.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title US+MRI
Hide Arm/Group Description The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals
All-Cause Mortality
US+MRI
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
US+MRI
Affected / at Risk (%)
Total   0/407 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
US+MRI
Affected / at Risk (%)
Total   0/407 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Professor Young-Suk Lim
Organization: Asan Medical Center, University of Ulsan College of Medicine
Phone: +82-02-3010-5933
Responsible Party: Young-Suk Lim, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01446666     History of Changes
Other Study ID Numbers: AMC2011-0587
First Submitted: September 17, 2011
First Posted: October 5, 2011
Results First Submitted: July 2, 2017
Results First Posted: January 14, 2019
Last Update Posted: January 14, 2019